Aurobindo Pharma Limited
FDA Approved Drugs
Aurobindo Pharma Limited
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 1128
- Latest Approval Date Aug 11, 2026
- Data Source FDA
- First Approval Date Dec 20, 1982
Company Overview
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Company Snapshot
Aurobindo Pharma Limited
Plot no. 2, Maitrivihar, Ameerpet, Hyderabad - 500038 Andhra Pradesh
India
www.aurobindo.com/ info@aurobindo.com View on MapFDA Approved Drug Records ( 1128 records )
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE
Application Number
22293
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-12-17
Active Ingredient
ABACAVIR SULFATE
Application Number
77844
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-12-17
Regulatory Status
RX
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
2018-03-14
Active Ingredient
ABACAVIR SULFATE
Application Number
77950
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
2018-03-14
Regulatory Status
RX
Drug Name
ABACAVIR SULFATE AND LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE;300MG
Approval Date
2018-11-15
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
90159
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE;300MG
Approval Date
2018-11-15
Regulatory Status
RX
Drug Name
ABACAVIR SULFATE AND LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE;300MG
Approval Date
2017-03-28
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
206151
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE;300MG
Approval Date
2017-03-28
Regulatory Status
Discontinued
Drug Name
ABACAVIR SULFATE; LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
60MG; 30MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
22295
Product Number
1
Dosage Form
-
Strength
60MG; 30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG
Approval Date
2016-11-09
Active Ingredient
ACETAMINOPHEN
Application Number
207229
Product Number
1
Dosage Form
-
Strength
650MG
Approval Date
2016-11-09
Regulatory Status
OTC
Drug Name
ACETAMINOPHEN AND IBUPROFEN
Product Number
1
Dosage Form
-
Strength
250MG;125MG
Approval Date
2024-03-26
Active Ingredient
ACETAMINOPHEN; IBUPROFEN
Application Number
218359
Product Number
1
Dosage Form
-
Strength
250MG;125MG
Approval Date
2024-03-26
Regulatory Status
OTC
Drug Name
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Product Number
1
Dosage Form
-
Strength
250MG;250MG;65MG
Approval Date
2022-02-02
Active Ingredient
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Application Number
211695
Product Number
1
Dosage Form
-
Strength
250MG;250MG;65MG
Approval Date
2022-02-02
Regulatory Status
OTC
Drug Name
ACETAZOLAMIDE
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2025-05-30
Active Ingredient
ACETAZOLAMIDE
Application Number
212089
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2025-05-30
Regulatory Status
RX
Drug Name
ACETAZOLAMIDE
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2025-05-30
Active Ingredient
ACETAZOLAMIDE
Application Number
212089
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2025-05-30
Regulatory Status
RX
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2022-03-31
Active Ingredient
ACYCLOVIR
Application Number
216331
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2022-03-31
Regulatory Status
RX
Drug Name
ADAPALENE AND BENZOYL PEROXIDE
Product Number
1
Dosage Form
-
Strength
0.3%;2.5%
Approval Date
2026-07-22
Active Ingredient
ADAPALENE; BENZOYL PEROXIDE
Application Number
217384
Product Number
1
Dosage Form
-
Strength
0.3%;2.5%
Approval Date
2026-07-22
Regulatory Status
RX
Drug Name
AFIRMELLE
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG
Approval Date
2016-11-14
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
206886
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG
Approval Date
2016-11-14
Regulatory Status
RX
Drug Name
ALBUTEROL SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2020-05-14
Active Ingredient
ALBUTEROL SULFATE
Application Number
213657
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2020-05-14
Regulatory Status
Discontinued
Drug Name
ALBUTEROL SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2020-05-14
Active Ingredient
ALBUTEROL SULFATE
Application Number
213657
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2020-05-14
Regulatory Status
Discontinued
Drug Name
ALENDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-08-04
Active Ingredient
ALENDRONATE SODIUM
Application Number
90124
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-08-04
Regulatory Status
RX
Drug Name
ALENDRONATE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 35MG BASE
Approval Date
2008-08-04
Active Ingredient
ALENDRONATE SODIUM
Application Number
90124
Product Number
2
Dosage Form
-
Strength
EQ 35MG BASE
Approval Date
2008-08-04
Regulatory Status
RX
Drug Name
ALENDRONATE SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 70MG BASE
Approval Date
2008-08-04
Active Ingredient
ALENDRONATE SODIUM
Application Number
90124
Product Number
3
Dosage Form
-
Strength
EQ 70MG BASE
Approval Date
2008-08-04
Regulatory Status
RX
Drug Name
ALFUZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2012-08-30
Active Ingredient
ALFUZOSIN HYDROCHLORIDE
Application Number
79060
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2012-08-30
Regulatory Status
RX
Drug Name
ALLOPURINOL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-04-14
Active Ingredient
ALLOPURINOL
Application Number
215091
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-04-14
Regulatory Status
RX
Drug Name
ALLOPURINOL
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-04-14
Active Ingredient
ALLOPURINOL
Application Number
215091
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-04-14
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2011-06-07
Active Ingredient
ALPRAZOLAM
Application Number
90871
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2011-06-07
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2011-06-07
Active Ingredient
ALPRAZOLAM
Application Number
90871
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2011-06-07
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2011-06-07
Active Ingredient
ALPRAZOLAM
Application Number
90871
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2011-06-07
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
4
Dosage Form
-
Strength
3MG
Approval Date
2011-06-07
Active Ingredient
ALPRAZOLAM
Application Number
90871
Product Number
4
Dosage Form
-
Strength
3MG
Approval Date
2011-06-07
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2015-07-31
Active Ingredient
ALPRAZOLAM
Application Number
203346
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2015-07-31
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2015-07-31
Active Ingredient
ALPRAZOLAM
Application Number
203346
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2015-07-31
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2015-07-31
Active Ingredient
ALPRAZOLAM
Application Number
203346
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2015-07-31
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2015-07-31
Active Ingredient
ALPRAZOLAM
Application Number
203346
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2015-07-31
Regulatory Status
RX
Drug Name
AMBRISENTAN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-07-21
Active Ingredient
AMBRISENTAN
Application Number
216531
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-07-21
Regulatory Status
RX
Drug Name
AMBRISENTAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-07-21
Active Ingredient
AMBRISENTAN
Application Number
216531
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-07-21
Regulatory Status
RX
Drug Name
AMINOCAPROIC ACID
Product Number
1
Dosage Form
-
Strength
0.25GM/ML
Approval Date
2022-09-26
Active Ingredient
AMINOCAPROIC ACID
Application Number
216804
Product Number
1
Dosage Form
-
Strength
0.25GM/ML
Approval Date
2022-09-26
Regulatory Status
RX
Drug Name
AMIODARONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2016-06-03
Active Ingredient
AMIODARONE HYDROCHLORIDE
Application Number
204742
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2016-06-03
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2017-05-15
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206906
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2017-05-15
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2017-05-15
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206906
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2017-05-15
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2017-05-15
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206906
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2017-05-15
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2017-05-15
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206906
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2017-05-15
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2007-07-17
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78021
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2007-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2007-07-17
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78021
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2007-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-07-17
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78021
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;10MG
Approval Date
2012-09-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
202239
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;10MG
Approval Date
2012-09-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;10MG
Approval Date
2012-09-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
202239
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;10MG
Approval Date
2012-09-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2012-09-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
202239
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2012-09-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2012-09-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
202239
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2012-09-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2012-09-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
202239
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2012-09-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2012-09-05
Active Ingredient
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Application Number
202239
Product Number
6
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2012-09-05
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2016-04-22
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
206512
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2016-04-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2016-04-22
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
206512
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2016-04-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2016-04-22
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
206512
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2016-04-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2016-04-22
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
206512
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2016-04-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;160MG
Approval Date
2017-12-19
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
206180
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;160MG
Approval Date
2017-12-19
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;25MG;160MG
Approval Date
2017-12-19
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
206180
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;25MG;160MG
Approval Date
2017-12-19
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;160MG
Approval Date
2017-12-19
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
206180
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;160MG
Approval Date
2017-12-19
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;25MG;160MG
Approval Date
2017-12-19
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
206180
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;25MG;160MG
Approval Date
2017-12-19
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;320MG
Approval Date
2017-12-19
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
206180
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;320MG
Approval Date
2017-12-19
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-11-09
Active Ingredient
AMOXICILLIN
Application Number
65256
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-11-09
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
875MG
Approval Date
2005-11-09
Active Ingredient
AMOXICILLIN
Application Number
65256
Product Number
2
Dosage Form
-
Strength
875MG
Approval Date
2005-11-09
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2005-11-09
Active Ingredient
AMOXICILLIN
Application Number
65271
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2005-11-09
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2005-11-09
Active Ingredient
AMOXICILLIN
Application Number
65271
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2005-11-09
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2007-01-17
Active Ingredient
AMOXICILLIN
Application Number
65324
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2007-01-17
Regulatory Status
Discontinued
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2007-01-17
Active Ingredient
AMOXICILLIN
Application Number
65324
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2007-01-17
Regulatory Status
Discontinued
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2006-12-28
Active Ingredient
AMOXICILLIN
Application Number
65334
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2006-12-28
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
400MG/5ML
Approval Date
2006-12-28
Active Ingredient
AMOXICILLIN
Application Number
65334
Product Number
2
Dosage Form
-
Strength
400MG/5ML
Approval Date
2006-12-28
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2014-09-15
Active Ingredient
AMOXICILLIN
Application Number
204030
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2014-09-15
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2014-09-15
Active Ingredient
AMOXICILLIN
Application Number
204030
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2014-09-15
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2012-01-20
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
91568
Product Number
1
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2012-01-20
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
250MG;EQ 125MG BASE
Approval Date
2012-01-20
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
91569
Product Number
1
Dosage Form
-
Strength
250MG;EQ 125MG BASE
Approval Date
2012-01-20
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
500MG;EQ 125MG BASE
Approval Date
2012-01-20
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
91569
Product Number
2
Dosage Form
-
Strength
500MG;EQ 125MG BASE
Approval Date
2012-01-20
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2011-12-20
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
201090
Product Number
1
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2011-12-20
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2011-12-20
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
201090
Product Number
2
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2011-12-20
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date
2011-12-20
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
201091
Product Number
1
Dosage Form
-
Strength
600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date
2011-12-20
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
125MG/5ML;EQ 31.25MG BASE/5ML
Approval Date
2019-04-19
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
209371
Product Number
1
Dosage Form
-
Strength
125MG/5ML;EQ 31.25MG BASE/5ML
Approval Date
2019-04-19
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date
2019-04-19
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
209371
Product Number
2
Dosage Form
-
Strength
250MG/5ML;EQ 62.5MG BASE/5ML
Approval Date
2019-04-19
Regulatory Status
RX
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2023-10-31
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
216554
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2023-10-31
Regulatory Status
RX
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2023-10-31
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
216554
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2023-10-31
Regulatory Status
RX
Drug Name
APIXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2023-05-26
Active Ingredient
APIXABAN
Application Number
210026
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2023-05-26
Regulatory Status
Discontinued
Drug Name
APIXABAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-05-26
Active Ingredient
APIXABAN
Application Number
210026
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-05-26
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-07-19
Active Ingredient
APREMILAST
Application Number
211716
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-07-19
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-07-19
Active Ingredient
APREMILAST
Application Number
211716
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-07-19
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-07-19
Active Ingredient
APREMILAST
Application Number
211716
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-07-19
Regulatory Status
Discontinued
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-10-08
Active Ingredient
ARIPIPRAZOLE
Application Number
203908
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-10-08
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-10-08
Active Ingredient
ARIPIPRAZOLE
Application Number
203908
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-10-08
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-10-08
Active Ingredient
ARIPIPRAZOLE
Application Number
203908
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-10-08
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2015-10-08
Active Ingredient
ARIPIPRAZOLE
Application Number
203908
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2015-10-08
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2015-10-08
Active Ingredient
ARIPIPRAZOLE
Application Number
203908
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2015-10-08
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2015-10-08
Active Ingredient
ARIPIPRAZOLE
Application Number
203908
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2015-10-08
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2019-01-29
Active Ingredient
ARIPIPRAZOLE
Application Number
210479
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2019-01-29
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2026-02-18
Active Ingredient
ARIPIPRAZOLE
Application Number
216208
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2026-02-18
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2026-02-18
Active Ingredient
ARIPIPRAZOLE
Application Number
216208
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2026-02-18
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2018-03-06
Active Ingredient
ARMODAFINIL
Application Number
206069
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2018-03-06
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2018-03-06
Active Ingredient
ARMODAFINIL
Application Number
206069
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2018-03-06
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2018-03-06
Active Ingredient
ARMODAFINIL
Application Number
206069
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2018-03-06
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2018-12-07
Active Ingredient
ARMODAFINIL
Application Number
206069
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2018-12-07
Regulatory Status
RX
Drug Name
ATAZANAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-06-25
Active Ingredient
ATAZANAVIR SULFATE
Application Number
204806
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-06-25
Regulatory Status
RX
Drug Name
ATAZANAVIR SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-06-25
Active Ingredient
ATAZANAVIR SULFATE
Application Number
204806
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-06-25
Regulatory Status
RX
Drug Name
ATAZANAVIR SULFATE
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2018-06-25
Active Ingredient
ATAZANAVIR SULFATE
Application Number
204806
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2018-06-25
Regulatory Status
RX
Drug Name
ATAZANAVIR SULFATE
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-06-25
Active Ingredient
ATAZANAVIR SULFATE
Application Number
204806
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-06-25
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2007-10-31
Active Ingredient
ATENOLOL
Application Number
78512
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2007-10-31
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2007-10-31
Active Ingredient
ATENOLOL
Application Number
78512
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2007-10-31
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2007-10-31
Active Ingredient
ATENOLOL
Application Number
78512
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2007-10-31
Regulatory Status
RX
Drug Name
ATHENTIA NEXT
Product Number
1
Dosage Form
-
Strength
1.5MG
Approval Date
2015-12-08
Active Ingredient
LEVONORGESTREL
Application Number
206867
Product Number
1
Dosage Form
-
Strength
1.5MG
Approval Date
2015-12-08
Regulatory Status
OTC
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 18MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
2
Dosage Form
-
Strength
EQ 18MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
5
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
6
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATOMOXETINE HYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-05-30
Active Ingredient
ATOMOXETINE HYDROCHLORIDE
Application Number
79016
Product Number
7
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-05-30
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-02-13
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217118
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-02-13
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-02-13
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217118
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-02-13
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-02-13
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217118
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-02-13
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-02-13
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217118
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-02-13
Regulatory Status
RX
Drug Name
AUROVELA 1.5/30
Product Number
1
Dosage Form
-
Strength
0.03MG;1.5MG
Approval Date
2017-06-26
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
207581
Product Number
1
Dosage Form
-
Strength
0.03MG;1.5MG
Approval Date
2017-06-26
Regulatory Status
RX
Drug Name
AUROVELA 1/20
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2017-06-16
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
207506
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2017-06-16
Regulatory Status
RX
Drug Name
AUROVELA 24 FE
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2017-06-15
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
207504
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2017-06-15
Regulatory Status
RX
Drug Name
AUROVELA FE 1.5/30
Product Number
1
Dosage Form
-
Strength
0.03MG;1.5MG
Approval Date
2017-06-15
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
207580
Product Number
1
Dosage Form
-
Strength
0.03MG;1.5MG
Approval Date
2017-06-15
Regulatory Status
RX
Drug Name
AUROVELA FE 1/20
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2017-06-16
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
207505
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2017-06-16
Regulatory Status
RX
Drug Name
AYUNA
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2016-09-23
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
206866
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2016-09-23
Regulatory Status
RX
Drug Name
AZELASTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY
Approval Date
2020-05-08
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
212289
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY
Approval Date
2020-05-08
Regulatory Status
RX
Drug Name
AZELASTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2020-11-12
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
212775
Product Number
1
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2020-11-12
Regulatory Status
Discontinued
Drug Name
AZELASTINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2025-01-27
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
216561
Product Number
1
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2025-01-27
Regulatory Status
OTC
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2018-07-05
Active Ingredient
AZITHROMYCIN
Application Number
207370
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2018-07-05
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2018-07-05
Active Ingredient
AZITHROMYCIN
Application Number
207398
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2018-07-05
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
2018-10-09
Active Ingredient
AZITHROMYCIN
Application Number
209201
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
2018-10-09
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
2018-10-09
Active Ingredient
AZITHROMYCIN
Application Number
209201
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/5ML
Approval Date
2018-10-09
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-07-13
Active Ingredient
BACLOFEN
Application Number
214099
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-07-13
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-07-13
Active Ingredient
BACLOFEN
Application Number
214099
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-07-13
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2025-11-21
Active Ingredient
BACLOFEN
Application Number
214099
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2025-11-21
Regulatory Status
RX
Drug Name
BARICITINIB
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2024-07-22
Active Ingredient
BARICITINIB
Application Number
217542
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2024-07-22
Regulatory Status
Discontinued
Drug Name
BARICITINIB
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2024-07-22
Active Ingredient
BARICITINIB
Application Number
217542
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2024-07-22
Regulatory Status
Discontinued
Drug Name
BENAZEPRIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2008-05-22
Active Ingredient
BENAZEPRIL HYDROCHLORIDE
Application Number
78212
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2008-05-22
Regulatory Status
RX
Drug Name
BENAZEPRIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2008-05-22
Active Ingredient
BENAZEPRIL HYDROCHLORIDE
Application Number
78212
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2008-05-22
Regulatory Status
RX
Drug Name
BENAZEPRIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2008-05-22
Active Ingredient
BENAZEPRIL HYDROCHLORIDE
Application Number
78212
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2008-05-22
Regulatory Status
RX
Drug Name
BETAMETHASONE DIPROPIONATE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
2024-04-10
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
218289
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
2024-04-10
Regulatory Status
RX
Drug Name
BETAMETHASONE DIPROPIONATE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
2026-01-26
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
219348
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
2026-01-26
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2006-12-27
Active Ingredient
BISOPROLOL FUMARATE
Application Number
77910
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2006-12-27
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2006-12-27
Active Ingredient
BISOPROLOL FUMARATE
Application Number
77910
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2006-12-27
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
2.5MG;6.25MG
Approval Date
2026-01-21
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
217922
Product Number
1
Dosage Form
-
Strength
2.5MG;6.25MG
Approval Date
2026-01-21
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2026-01-21
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
217922
Product Number
2
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2026-01-21
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
10MG;6.25MG
Approval Date
2026-01-21
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
217922
Product Number
3
Dosage Form
-
Strength
10MG;6.25MG
Approval Date
2026-01-21
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2023-11-02
Active Ingredient
BREXPIPRAZOLE
Application Number
213659
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2023-11-02
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2023-11-02
Active Ingredient
BREXPIPRAZOLE
Application Number
213659
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2023-11-02
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2023-11-02
Active Ingredient
BREXPIPRAZOLE
Application Number
213659
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2023-11-02
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2023-11-02
Active Ingredient
BREXPIPRAZOLE
Application Number
213659
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2023-11-02
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2023-11-02
Active Ingredient
BREXPIPRAZOLE
Application Number
213659
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2023-11-02
Regulatory Status
Discontinued
Drug Name
BREXPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2023-11-02
Active Ingredient
BREXPIPRAZOLE
Application Number
213659
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2023-11-02
Regulatory Status
Discontinued
Drug Name
BRIVARACETAM
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2023-01-06
Active Ingredient
BRIVARACETAM
Application Number
214848
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2023-01-06
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2023-01-06
Active Ingredient
BRIVARACETAM
Application Number
214848
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2023-01-06
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2026-07-13
Active Ingredient
BRIVARACETAM
Application Number
214848
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2026-07-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2026-07-13
Active Ingredient
BRIVARACETAM
Application Number
214848
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2026-07-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2026-07-13
Active Ingredient
BRIVARACETAM
Application Number
214848
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2026-07-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-08-10
Active Ingredient
BRIVARACETAM
Application Number
220288
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-08-10
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2026-07-21
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
216051
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2026-07-21
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2026-07-21
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
216051
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2026-07-21
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2009-02-27
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
78246
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2009-02-27
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-02-27
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
78246
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-02-27
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2009-02-27
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
78246
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2009-02-27
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2009-02-27
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
78246
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2009-02-27
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
7.5MG
Approval Date
2020-02-21
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
78246
Product Number
5
Dosage Form
-
Strength
7.5MG
Approval Date
2020-02-21
Regulatory Status
RX
Drug Name
CANAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2026-04-20
Active Ingredient
CANAGLIFLOZIN
Application Number
210386
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2026-04-20
Regulatory Status
Discontinued
Drug Name
CANAGLIFLOZIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2026-04-20
Active Ingredient
CANAGLIFLOZIN
Application Number
210386
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2026-04-20
Regulatory Status
Discontinued
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application Number
213900
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application Number
213900
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application Number
213900
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CARBIDOPA
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-10-21
Active Ingredient
CARBIDOPA
Application Number
211055
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-10-21
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
1
Dosage Form
-
Strength
10MG;100MG
Approval Date
2022-11-28
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
216537
Product Number
1
Dosage Form
-
Strength
10MG;100MG
Approval Date
2022-11-28
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2022-11-28
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
216537
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2022-11-28
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
3
Dosage Form
-
Strength
25MG;250MG
Approval Date
2022-11-28
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
216537
Product Number
3
Dosage Form
-
Strength
25MG;250MG
Approval Date
2022-11-28
Regulatory Status
RX
Drug Name
CARIPRAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2025-12-16
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
213982
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2025-12-16
Regulatory Status
Discontinued
Drug Name
CARIPRAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2025-12-16
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
213982
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2025-12-16
Regulatory Status
Discontinued
Drug Name
CARIPRAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2025-12-16
Active Ingredient
CARIPRAZINE HYDROCHLORIDE
Application Number
213982
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2025-12-16
Regulatory Status
Discontinued
Drug Name
CARISOPRODOL
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
2009-08-06
Active Ingredient
CARISOPRODOL
Application Number
40792
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
2009-08-06
Regulatory Status
RX
Drug Name
CARISOPRODOL
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2016-11-08
Active Ingredient
CARISOPRODOL
Application Number
40792
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2016-11-08
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
1
Dosage Form
-
Strength
3.125MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78332
Product Number
1
Dosage Form
-
Strength
3.125MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
2
Dosage Form
-
Strength
6.25MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78332
Product Number
2
Dosage Form
-
Strength
6.25MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
3
Dosage Form
-
Strength
12.5MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78332
Product Number
3
Dosage Form
-
Strength
12.5MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CARVEDILOL
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2007-09-05
Active Ingredient
CARVEDILOL
Application Number
78332
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2007-09-05
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2013-04-25
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
65349
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2013-04-25
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML
Approval Date
2013-04-25
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
65349
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML
Approval Date
2013-04-25
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2007-01-25
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
65352
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2007-01-25
Regulatory Status
RX
Drug Name
CEFAZOLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-08-08
Active Ingredient
CEFAZOLIN SODIUM
Application Number
65395
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-08-08
Regulatory Status
Discontinued
Drug Name
CEFAZOLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-08-08
Active Ingredient
CEFAZOLIN SODIUM
Application Number
65395
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-08-08
Regulatory Status
Discontinued
Drug Name
CEFDINIR
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2008-01-07
Active Ingredient
CEFDINIR
Application Number
65434
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2008-01-07
Regulatory Status
RX
Drug Name
CEFDINIR
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-12-14
Active Ingredient
CEFDINIR
Application Number
65473
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-12-14
Regulatory Status
RX
Drug Name
CEFDINIR
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-12-14
Active Ingredient
CEFDINIR
Application Number
65473
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-12-14
Regulatory Status
RX
Drug Name
CEFIXIME
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2015-04-14
Active Ingredient
CEFIXIME
Application Number
204835
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2015-04-14
Regulatory Status
RX
Drug Name
CEFIXIME
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2015-04-14
Active Ingredient
CEFIXIME
Application Number
204835
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2015-04-14
Regulatory Status
RX
Drug Name
CEFIXIME
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2026-03-23
Active Ingredient
CEFIXIME
Application Number
217607
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2026-03-23
Regulatory Status
RX
Drug Name
CEFOTAXIME SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2009-11-06
Active Ingredient
CEFOTAXIME SODIUM
Application Number
65516
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2009-11-06
Regulatory Status
Discontinued
Drug Name
CEFOTAXIME SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2009-11-06
Active Ingredient
CEFOTAXIME SODIUM
Application Number
65517
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2009-11-06
Regulatory Status
Discontinued
Drug Name
CEFOTAXIME SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2009-11-06
Active Ingredient
CEFOTAXIME SODIUM
Application Number
65517
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2009-11-06
Regulatory Status
Discontinued
Drug Name
CEFOTAXIME SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2009-11-06
Active Ingredient
CEFOTAXIME SODIUM
Application Number
65517
Product Number
3
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2009-11-06
Regulatory Status
Discontinued
Drug Name
CEFPODOXIME PROXETIL
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-06-11
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
65370
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-06-11
Regulatory Status
RX
Drug Name
CEFPODOXIME PROXETIL
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2007-06-11
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
65370
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2007-06-11
Regulatory Status
RX
Drug Name
CEFPODOXIME PROXETIL
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML
Approval Date
2007-06-08
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
65409
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/5ML
Approval Date
2007-06-08
Regulatory Status
RX
Drug Name
CEFPODOXIME PROXETIL
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
2007-06-08
Active Ingredient
CEFPODOXIME PROXETIL
Application Number
65409
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/5ML
Approval Date
2007-06-08
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2007-05-24
Active Ingredient
CEFPROZIL
Application Number
65340
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2007-05-24
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2007-05-24
Active Ingredient
CEFPROZIL
Application Number
65340
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2007-05-24
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-01-30
Active Ingredient
CEFPROZIL
Application Number
65381
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2007-01-30
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-01-30
Active Ingredient
CEFPROZIL
Application Number
65381
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-01-30
Regulatory Status
RX
Drug Name
CEFTAZIDIME
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2010-05-28
Active Ingredient
CEFTAZIDIME
Application Number
65481
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2010-05-28
Regulatory Status
Discontinued
Drug Name
CEFTAZIDIME
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2010-05-28
Active Ingredient
CEFTAZIDIME
Application Number
65481
Product Number
2
Dosage Form
-
Strength
1GM/VIAL
Approval Date
2010-05-28
Regulatory Status
Discontinued
Drug Name
CEFTAZIDIME
Product Number
3
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2010-05-28
Active Ingredient
CEFTAZIDIME
Application Number
65481
Product Number
3
Dosage Form
-
Strength
2GM/VIAL
Approval Date
2010-05-28
Regulatory Status
Discontinued
Drug Name
CEFTAZIDIME
Product Number
1
Dosage Form
-
Strength
6GM/VIAL
Approval Date
2010-05-28
Active Ingredient
CEFTAZIDIME
Application Number
65482
Product Number
1
Dosage Form
-
Strength
6GM/VIAL
Approval Date
2010-05-28
Regulatory Status
Discontinued
Drug Name
CEFTRIAXONE
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2008-07-31
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65504
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2008-07-31
Regulatory Status
Discontinued
Drug Name
CEFTRIAXONE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2008-07-31
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65505
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2008-07-31
Regulatory Status
Discontinued
Drug Name
CEFTRIAXONE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-07-31
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65505
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-07-31
Regulatory Status
Discontinued
Drug Name
CEFTRIAXONE
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-07-31
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65505
Product Number
3
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-07-31
Regulatory Status
Discontinued
Drug Name
CEFTRIAXONE
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2008-07-31
Active Ingredient
CEFTRIAXONE SODIUM
Application Number
65505
Product Number
4
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2008-07-31
Regulatory Status
Discontinued
Drug Name
CEFUROXIME AXETIL
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE
Approval Date
2006-03-29
Active Ingredient
CEFUROXIME AXETIL
Application Number
65308
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE
Approval Date
2006-03-29
Regulatory Status
RX
Drug Name
CEFUROXIME AXETIL
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2006-03-29
Active Ingredient
CEFUROXIME AXETIL
Application Number
65308
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2006-03-29
Regulatory Status
RX
Drug Name
CEFUROXIME AXETIL
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2006-03-29
Active Ingredient
CEFUROXIME AXETIL
Application Number
65308
Product Number
3
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2006-03-29
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2016-02-01
Active Ingredient
CELECOXIB
Application Number
206827
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2016-02-01
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2016-02-01
Active Ingredient
CELECOXIB
Application Number
206827
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2016-02-01
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2016-02-01
Active Ingredient
CELECOXIB
Application Number
206827
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2016-02-01
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2016-02-01
Active Ingredient
CELECOXIB
Application Number
206827
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2016-02-01
Regulatory Status
RX
Drug Name
CENOBAMATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
CENOBAMATE
Application Number
219473
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CENOBAMATE
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
CENOBAMATE
Application Number
219473
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CENOBAMATE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
CENOBAMATE
Application Number
219473
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CENOBAMATE
Product Number
5
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
CENOBAMATE
Application Number
219473
Product Number
5
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CENOBAMATE
Product Number
6
Dosage Form
-
Strength
12.5MG
Approval Date
-
Active Ingredient
CENOBAMATE
Application Number
219473
Product Number
6
Dosage Form
-
Strength
12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CEPHALEXIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2005-11-16
Active Ingredient
CEPHALEXIN
Application Number
65253
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2005-11-16
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2005-11-16
Active Ingredient
CEPHALEXIN
Application Number
65253
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2005-11-16
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
3
Dosage Form
-
Strength
EQ 750MG BASE
Approval Date
2023-12-06
Active Ingredient
CEPHALEXIN
Application Number
65253
Product Number
3
Dosage Form
-
Strength
EQ 750MG BASE
Approval Date
2023-12-06
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
2026-06-09
Active Ingredient
CEPHALEXIN
Application Number
213568
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
2026-06-09
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2026-06-09
Active Ingredient
CEPHALEXIN
Application Number
213568
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2026-06-09
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2024-09-27
Active Ingredient
CEPHALEXIN
Application Number
218817
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2024-09-27
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2024-09-27
Active Ingredient
CEPHALEXIN
Application Number
218817
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2024-09-27
Regulatory Status
RX
Drug Name
CETIRIZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2009-12-16
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90751
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2009-12-16
Regulatory Status
Discontinued
Drug Name
CETIRIZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-09-11
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
213557
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-09-11
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-08-05
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90760
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-08-05
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-08-05
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90760
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-08-05
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-07-20
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
209107
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-07-20
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG;120MG
Approval Date
2023-03-08
Active Ingredient
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
212409
Product Number
1
Dosage Form
-
Strength
5MG;120MG
Approval Date
2023-03-08
Regulatory Status
Discontinued
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-08-05
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90760
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-08-05
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2015-08-05
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90760
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2015-08-05
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2018-07-20
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
209107
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2018-07-20
Regulatory Status
OTC
Drug Name
CEVIMELINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2023-04-18
Active Ingredient
CEVIMELINE HYDROCHLORIDE
Application Number
215056
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2023-04-18
Regulatory Status
RX
Drug Name
CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
2
Dosage Form
-
Strength
5MG/5ML
Approval Date
2010-02-02
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90750
Product Number
2
Dosage Form
-
Strength
5MG/5ML
Approval Date
2010-02-02
Regulatory Status
OTC
Drug Name
CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2010-02-02
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
90750
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2010-02-02
Regulatory Status
OTC
Drug Name
CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2014-11-19
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
202039
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2014-11-19
Regulatory Status
OTC
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2023-09-14
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Application Number
216419
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2023-09-14
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-04-25
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216788
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-04-25
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2025-04-25
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216788
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2025-04-25
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2025-04-25
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216788
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2025-04-25
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2025-04-25
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216788
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2025-04-25
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2025-04-25
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216788
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2025-04-25
Regulatory Status
RX
Drug Name
CHLORZOXAZONE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1988-05-04
Active Ingredient
CHLORZOXAZONE
Application Number
89853
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1988-05-04
Regulatory Status
RX
Drug Name
CHLORZOXAZONE
Product Number
2
Dosage Form
-
Strength
375MG
Approval Date
2023-08-17
Active Ingredient
CHLORZOXAZONE
Application Number
89853
Product Number
2
Dosage Form
-
Strength
375MG
Approval Date
2023-08-17
Regulatory Status
RX
Drug Name
CHLORZOXAZONE
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2023-08-17
Active Ingredient
CHLORZOXAZONE
Application Number
89853
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2023-08-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-11-12
Active Ingredient
CIMETIDINE
Application Number
218997
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-11-12
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2024-11-12
Active Ingredient
CIMETIDINE
Application Number
218997
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2024-11-12
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2024-11-12
Active Ingredient
CIMETIDINE
Application Number
218997
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2024-11-12
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2024-11-12
Active Ingredient
CIMETIDINE
Application Number
218997
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2024-11-12
Regulatory Status
RX
Drug Name
CINACALCET HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2018-03-08
Active Ingredient
CINACALCET HYDROCHLORIDE
Application Number
206125
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2018-03-08
Regulatory Status
RX
Drug Name
CINACALCET HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2018-03-08
Active Ingredient
CINACALCET HYDROCHLORIDE
Application Number
206125
Product Number
2
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2018-03-08
Regulatory Status
RX
Drug Name
CINACALCET HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2018-03-08
Active Ingredient
CINACALCET HYDROCHLORIDE
Application Number
206125
Product Number
3
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2018-03-08
Regulatory Status
RX
Drug Name
CIPROFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2007-04-26
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
77859
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2007-04-26
Regulatory Status
RX
Drug Name
CIPROFLOXACIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2007-04-26
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
77859
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2007-04-26
Regulatory Status
RX
Drug Name
CIPROFLOXACIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 750MG BASE
Approval Date
2007-04-26
Active Ingredient
CIPROFLOXACIN HYDROCHLORIDE
Application Number
77859
Product Number
3
Dosage Form
-
Strength
EQ 750MG BASE
Approval Date
2007-04-26
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2004-10-28
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77031
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2004-10-28
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2004-10-28
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77031
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2004-10-28
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2004-10-28
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77031
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2004-10-28
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2006-08-28
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77812
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2006-08-28
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2026-03-13
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
219985
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2026-03-13
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2012-07-25
Active Ingredient
CLARITHROMYCIN
Application Number
65489
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2012-07-25
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2012-07-25
Active Ingredient
CLARITHROMYCIN
Application Number
65489
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2012-07-25
Regulatory Status
RX
Drug Name
CLINDAMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2009-08-26
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
65442
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2009-08-26
Regulatory Status
RX
Drug Name
CLINDAMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2009-08-26
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
65442
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2009-08-26
Regulatory Status
RX
Drug Name
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/5ML
Approval Date
2013-04-30
Active Ingredient
CLINDAMYCIN PALMITATE HYDROCHLORIDE
Application Number
202409
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE/5ML
Approval Date
2013-04-30
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
2026-03-18
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
218942
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
2026-03-18
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2022-03-24
Active Ingredient
CLOBAZAM
Application Number
214404
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2022-03-24
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-03-20
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
216440
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-03-20
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-03-20
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
216440
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-03-20
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2023-03-20
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
216440
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2023-03-20
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.2MG
Approval Date
1988-08-31
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
70886
Product Number
1
Dosage Form
-
Strength
0.2MG
Approval Date
1988-08-31
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.1MG
Approval Date
1988-08-31
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
70886
Product Number
2
Dosage Form
-
Strength
0.1MG
Approval Date
1988-08-31
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.3MG
Approval Date
1988-08-31
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
70886
Product Number
3
Dosage Form
-
Strength
0.3MG
Approval Date
1988-08-31
Regulatory Status
RX
Drug Name
CLOPIDOGREL BISULFATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2012-05-17
Active Ingredient
CLOPIDOGREL BISULFATE
Application Number
90540
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2012-05-17
Regulatory Status
RX
Drug Name
CLORAZEPATE DIPOTASSIUM
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1987-07-17
Active Ingredient
CLORAZEPATE DIPOTASSIUM
Application Number
71858
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1987-07-17
Regulatory Status
RX
Drug Name
CLORAZEPATE DIPOTASSIUM
Product Number
2
Dosage Form
-
Strength
3.75MG
Approval Date
1987-07-17
Active Ingredient
CLORAZEPATE DIPOTASSIUM
Application Number
71858
Product Number
2
Dosage Form
-
Strength
3.75MG
Approval Date
1987-07-17
Regulatory Status
RX
Drug Name
CLORAZEPATE DIPOTASSIUM
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
1987-07-17
Active Ingredient
CLORAZEPATE DIPOTASSIUM
Application Number
71858
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
1987-07-17
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2016-11-29
Active Ingredient
CLOZAPINE
Application Number
206433
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2016-11-29
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2016-11-29
Active Ingredient
CLOZAPINE
Application Number
206433
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2016-11-29
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2016-11-29
Active Ingredient
CLOZAPINE
Application Number
206433
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2016-11-29
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2016-11-29
Active Ingredient
CLOZAPINE
Application Number
206433
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2016-11-29
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2024-12-12
Active Ingredient
CLOZAPINE
Application Number
212923
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2024-12-12
Active Ingredient
CLOZAPINE
Application Number
212923
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2024-12-12
Active Ingredient
CLOZAPINE
Application Number
212923
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
2024-12-12
Active Ingredient
CLOZAPINE
Application Number
212923
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2024-12-12
Active Ingredient
CLOZAPINE
Application Number
212923
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2022-01-06
Active Ingredient
COLCHICINE
Application Number
215444
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2022-01-06
Regulatory Status
RX
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2024-04-29
Active Ingredient
COLCHICINE
Application Number
215463
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2024-04-29
Regulatory Status
RX
Drug Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-09-26
Active Ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Application Number
78643
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-09-26
Regulatory Status
RX
Drug Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-09-26
Active Ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Application Number
78643
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-09-26
Regulatory Status
RX
Drug Name
CYONANZ
Product Number
1
Dosage Form
-
Strength
0.035MG;0.5MG
Approval Date
2016-10-21
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
207055
Product Number
1
Dosage Form
-
Strength
0.035MG;0.5MG
Approval Date
2016-10-21
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-05-14
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208039
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 110MG BASE
Approval Date
2025-05-14
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208039
Product Number
2
Dosage Form
-
Strength
EQ 110MG BASE
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-05-14
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208039
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
DALFAMPRIDINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-01-23
Active Ingredient
DALFAMPRIDINE
Application Number
206811
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-01-23
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211468
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211468
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG;500MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211489
Product Number
1
Dosage Form
-
Strength
5MG;500MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG;1GM
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211489
Product Number
2
Dosage Form
-
Strength
5MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG;500MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211489
Product Number
3
Dosage Form
-
Strength
10MG;500MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211489
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
-
Active Ingredient
DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application Number
211489
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2025-04-04
Active Ingredient
DAPSONE
Application Number
218457
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2025-04-04
Regulatory Status
RX
Drug Name
DARIFENACIN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2016-09-19
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
206743
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2016-09-19
Regulatory Status
RX
Drug Name
DARIFENACIN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2016-09-19
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
206743
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2016-09-19
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2023-11-28
Active Ingredient
DARUNAVIR
Application Number
210677
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2023-11-28
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-11-28
Active Ingredient
DARUNAVIR
Application Number
210677
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-11-28
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2023-10-16
Active Ingredient
DEFERASIROX
Application Number
214474
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2023-10-16
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2023-10-16
Active Ingredient
DEFERASIROX
Application Number
214474
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2023-10-16
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
360MG
Approval Date
2023-10-16
Active Ingredient
DEFERASIROX
Application Number
214474
Product Number
3
Dosage Form
-
Strength
360MG
Approval Date
2023-10-16
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2025-09-08
Active Ingredient
DEFERASIROX
Application Number
215137
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2025-09-08
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2025-09-08
Active Ingredient
DEFERASIROX
Application Number
215137
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2025-09-08
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
360MG
Approval Date
2025-09-08
Active Ingredient
DEFERASIROX
Application Number
215137
Product Number
3
Dosage Form
-
Strength
360MG
Approval Date
2025-09-08
Regulatory Status
RX
Drug Name
DEFLAZACORT
Product Number
1
Dosage Form
-
Strength
6MG
Approval Date
2024-02-09
Active Ingredient
DEFLAZACORT
Application Number
217123
Product Number
1
Dosage Form
-
Strength
6MG
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
DEFLAZACORT
Product Number
2
Dosage Form
-
Strength
18MG
Approval Date
2024-02-09
Active Ingredient
DEFLAZACORT
Application Number
217123
Product Number
2
Dosage Form
-
Strength
18MG
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
DEFLAZACORT
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-02-09
Active Ingredient
DEFLAZACORT
Application Number
217123
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
DEFLAZACORT
Product Number
4
Dosage Form
-
Strength
36MG
Approval Date
2024-02-09
Active Ingredient
DEFLAZACORT
Application Number
217123
Product Number
4
Dosage Form
-
Strength
36MG
Approval Date
2024-02-09
Regulatory Status
RX
Drug Name
DESMOPRESSIN ACETATE
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
2024-03-21
Active Ingredient
DESMOPRESSIN ACETATE
Application Number
213095
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
2024-03-21
Regulatory Status
RX
Drug Name
DESMOPRESSIN ACETATE
Product Number
2
Dosage Form
-
Strength
0.2MG
Approval Date
2024-03-21
Active Ingredient
DESMOPRESSIN ACETATE
Application Number
213095
Product Number
2
Dosage Form
-
Strength
0.2MG
Approval Date
2024-03-21
Regulatory Status
RX
Drug Name
DEUTETRABENAZINE
Product Number
1
Dosage Form
-
Strength
6MG
Approval Date
2024-12-26
Active Ingredient
DEUTETRABENAZINE
Application Number
215971
Product Number
1
Dosage Form
-
Strength
6MG
Approval Date
2024-12-26
Regulatory Status
Discontinued
Drug Name
DEUTETRABENAZINE
Product Number
2
Dosage Form
-
Strength
9MG
Approval Date
2024-12-26
Active Ingredient
DEUTETRABENAZINE
Application Number
215971
Product Number
2
Dosage Form
-
Strength
9MG
Approval Date
2024-12-26
Regulatory Status
Discontinued
Drug Name
DEUTETRABENAZINE
Product Number
3
Dosage Form
-
Strength
12MG
Approval Date
2024-12-26
Active Ingredient
DEUTETRABENAZINE
Application Number
215971
Product Number
3
Dosage Form
-
Strength
12MG
Approval Date
2024-12-26
Regulatory Status
Discontinued
Drug Name
DEXTROMETHORPHAN POLISTIREX
Product Number
1
Dosage Form
-
Strength
EQ 30MG HYDROBROMIDE/5ML
Approval Date
2026-04-15
Active Ingredient
DEXTROMETHORPHAN POLISTIREX
Application Number
218417
Product Number
1
Dosage Form
-
Strength
EQ 30MG HYDROBROMIDE/5ML
Approval Date
2026-04-15
Regulatory Status
OTC
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2023-12-14
Active Ingredient
DIAZEPAM
Application Number
217843
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2023-12-14
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-12-14
Active Ingredient
DIAZEPAM
Application Number
217843
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-12-14
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2023-12-14
Active Ingredient
DIAZEPAM
Application Number
217843
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2023-12-14
Regulatory Status
RX
Drug Name
DICLOFENAC POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2021-10-19
Active Ingredient
DICLOFENAC POTASSIUM
Application Number
213875
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2021-10-19
Regulatory Status
RX
Drug Name
DICLOXACILLIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2022-09-23
Active Ingredient
DICLOXACILLIN SODIUM
Application Number
216845
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2022-09-23
Regulatory Status
RX
Drug Name
DICLOXACILLIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2022-09-23
Active Ingredient
DICLOXACILLIN SODIUM
Application Number
216845
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2022-09-23
Regulatory Status
RX
Drug Name
DIDANOSINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-08-14
Active Ingredient
DIDANOSINE
Application Number
77275
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-08-14
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-08-14
Active Ingredient
DIDANOSINE
Application Number
77275
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-08-14
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2012-08-14
Active Ingredient
DIDANOSINE
Application Number
77275
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2012-08-14
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2007-03-08
Active Ingredient
DIDANOSINE
Application Number
78112
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2007-03-08
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2008-09-24
Active Ingredient
DIDANOSINE
Application Number
90094
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2008-09-24
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2008-09-24
Active Ingredient
DIDANOSINE
Application Number
90094
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2008-09-24
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2008-09-24
Active Ingredient
DIDANOSINE
Application Number
90094
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2008-09-24
Regulatory Status
Discontinued
Drug Name
DIDANOSINE
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2008-09-24
Active Ingredient
DIDANOSINE
Application Number
90094
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2008-09-24
Regulatory Status
Discontinued
Drug Name
DIGOXIN
Product Number
1
Dosage Form
-
Strength
0.0625MG
Approval Date
2022-02-08
Active Ingredient
DIGOXIN
Application Number
214982
Product Number
1
Dosage Form
-
Strength
0.0625MG
Approval Date
2022-02-08
Regulatory Status
RX
Drug Name
DIGOXIN
Product Number
2
Dosage Form
-
Strength
0.125MG
Approval Date
2022-02-08
Active Ingredient
DIGOXIN
Application Number
214982
Product Number
2
Dosage Form
-
Strength
0.125MG
Approval Date
2022-02-08
Regulatory Status
RX
Drug Name
DIGOXIN
Product Number
3
Dosage Form
-
Strength
0.25MG
Approval Date
2022-02-08
Active Ingredient
DIGOXIN
Application Number
214982
Product Number
3
Dosage Form
-
Strength
0.25MG
Approval Date
2022-02-08
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2022-12-22
Active Ingredient
DIMETHYL FUMARATE
Application Number
210385
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2022-12-22
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2022-12-22
Active Ingredient
DIMETHYL FUMARATE
Application Number
210385
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2022-12-22
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2011-04-21
Active Ingredient
DIVALPROEX SODIUM
Application Number
90554
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2011-04-21
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2011-04-21
Active Ingredient
DIVALPROEX SODIUM
Application Number
90554
Product Number
2
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2011-04-21
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2011-04-21
Active Ingredient
DIVALPROEX SODIUM
Application Number
90554
Product Number
3
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2011-04-21
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2014-06-02
Active Ingredient
DIVALPROEX SODIUM
Application Number
202419
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2014-06-02
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2014-06-02
Active Ingredient
DIVALPROEX SODIUM
Application Number
202419
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2014-06-02
Regulatory Status
RX
Drug Name
DOCOSANOL
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2024-03-01
Active Ingredient
DOCOSANOL
Application Number
217090
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2024-03-01
Regulatory Status
OTC
Drug Name
DOFETILDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2019-01-22
Active Ingredient
DOFETILIDE
Application Number
210740
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2019-01-22
Regulatory Status
RX
Drug Name
DOFETILDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2019-01-22
Active Ingredient
DOFETILIDE
Application Number
210740
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2019-01-22
Regulatory Status
RX
Drug Name
DOFETILDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2019-01-22
Active Ingredient
DOFETILIDE
Application Number
210740
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2019-01-22
Regulatory Status
RX
Drug Name
DOLUTEGRAVIR SODIUM
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR SODIUM
Application Number
208355
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-05-31
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
90056
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-05-31
Regulatory Status
RX
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-05-31
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
90056
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-05-31
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-03-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
211603
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2019-03-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
211603
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2019-03-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
211603
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2019-03-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
211603
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2019-03-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
211603
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2019-03-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2024-07-25
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
216041
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2024-07-25
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2024-07-25
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
216041
Product Number
2
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2024-07-25
Regulatory Status
RX
Drug Name
DRONEDARONE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
-
Active Ingredient
DRONEDARONE
Application Number
210678
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DROXIDOPA
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2021-02-18
Active Ingredient
DROXIDOPA
Application Number
214387
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2021-02-18
Regulatory Status
RX
Drug Name
DROXIDOPA
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2021-02-18
Active Ingredient
DROXIDOPA
Application Number
214387
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2021-02-18
Regulatory Status
RX
Drug Name
DROXIDOPA
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2021-02-18
Active Ingredient
DROXIDOPA
Application Number
214387
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2021-02-18
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90778
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90778
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90778
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
DUTASTERIDE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2015-11-20
Active Ingredient
DUTASTERIDE
Application Number
202660
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2015-11-20
Regulatory Status
RX
Drug Name
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.5MG;0.4MG
Approval Date
2024-07-18
Active Ingredient
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
Application Number
213300
Product Number
1
Dosage Form
-
Strength
0.5MG;0.4MG
Approval Date
2024-07-18
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2018-09-21
Active Ingredient
EFAVIRENZ
Application Number
77673
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2018-09-21
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2017-12-15
Active Ingredient
EFAVIRENZ
Application Number
78064
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2017-12-15
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2017-12-15
Active Ingredient
EFAVIRENZ
Application Number
78064
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2017-12-15
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2017-12-15
Active Ingredient
EFAVIRENZ
Application Number
78064
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2017-12-15
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2018-08-30
Active Ingredient
EFAVIRENZ
Application Number
205322
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2018-08-30
Regulatory Status
Discontinued
Drug Name
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG;200MG;300MG
Approval Date
2018-09-04
Active Ingredient
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
203041
Product Number
1
Dosage Form
-
Strength
600MG;200MG;300MG
Approval Date
2018-09-04
Regulatory Status
RX
Drug Name
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
2018-08-15
Active Ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
22343
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
2018-08-15
Regulatory Status
Discontinued
Drug Name
EFINACONAZOLE
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2021-03-29
Active Ingredient
EFINACONAZOLE
Application Number
212066
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2021-03-29
Regulatory Status
Discontinued
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-01-15
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
210708
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-01-15
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-01-15
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
210708
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-01-15
Regulatory Status
RX
Drug Name
ELUXADOLINE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2026-06-02
Active Ingredient
ELUXADOLINE
Application Number
213511
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2026-06-02
Regulatory Status
Discontinued
Drug Name
ELUXADOLINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2026-06-02
Active Ingredient
ELUXADOLINE
Application Number
213511
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2026-06-02
Regulatory Status
Discontinued
Drug Name
EMPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN
Application Number
212371
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN
Application Number
212371
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG/850MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application Number
212374
Product Number
2
Dosage Form
-
Strength
5MG/850MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG/500MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
Application Number
212374
Product Number
3
Dosage Form
-
Strength
5MG/500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMTRICITABINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2023-03-15
Active Ingredient
EMTRICITABINE
Application Number
79188
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2023-03-15
Regulatory Status
RX
Drug Name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG;300MG
Approval Date
2018-01-26
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
90513
Product Number
1
Dosage Form
-
Strength
200MG;300MG
Approval Date
2018-01-26
Regulatory Status
RX
Drug Name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
100MG;150MG
Approval Date
2023-03-09
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
211640
Product Number
1
Dosage Form
-
Strength
100MG;150MG
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
2
Dosage Form
-
Strength
133MG;200MG
Approval Date
2023-03-09
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
211640
Product Number
2
Dosage Form
-
Strength
133MG;200MG
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
3
Dosage Form
-
Strength
167MG;250MG
Approval Date
2023-03-09
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
211640
Product Number
3
Dosage Form
-
Strength
167MG;250MG
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
EMTRICITABINE; TENOFOVIR ALAFENAMIDE
Product Number
1
Dosage Form
-
Strength
200MG/25MG
Approval Date
-
Active Ingredient
EMTRICITABINE;TENOFOVIR ALAFENAMIDE
Application Number
216875
Product Number
1
Dosage Form
-
Strength
200MG/25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMZAHH
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2023-01-06
Active Ingredient
NORETHINDRONE
Application Number
216796
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2023-01-06
Regulatory Status
RX
Drug Name
ENALAPRIL MALEATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-01-08
Active Ingredient
ENALAPRIL MALEATE
Application Number
216458
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-01-08
Regulatory Status
RX
Drug Name
ENTACAPONE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2015-06-19
Active Ingredient
ENTACAPONE
Application Number
203437
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2015-06-19
Regulatory Status
RX
Drug Name
ENTECAVIR
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2015-08-26
Active Ingredient
ENTECAVIR
Application Number
206217
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2015-08-26
Regulatory Status
RX
Drug Name
ENTECAVIR
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2015-08-26
Active Ingredient
ENTECAVIR
Application Number
206217
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2015-08-26
Regulatory Status
RX
Drug Name
ERTUGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-07-13
Active Ingredient
ERTUGLIFLOZIN
Application Number
216947
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-07-13
Regulatory Status
Discontinued
Drug Name
ERTUGLIFLOZIN
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2023-07-13
Active Ingredient
ERTUGLIFLOZIN
Application Number
216947
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2023-07-13
Regulatory Status
Discontinued
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/5ML
Approval Date
2012-04-02
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
79062
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/5ML
Approval Date
2012-04-02
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
90432
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-09-11
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
90432
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-09-11
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
90432
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-09-11
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2026-08-05
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
216481
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2026-08-05
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2026-08-05
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
216481
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2026-08-05
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2026-08-05
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
216481
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2026-08-05
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2026-08-05
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
216481
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2026-08-05
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-04-21
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
205606
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-04-21
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-04-21
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
205606
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-04-21
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-10-16
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
209339
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-10-16
Regulatory Status
OTC
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2023-07-12
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
214473
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2023-07-12
Regulatory Status
OTC
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/PACKET
Approval Date
2025-04-15
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
218948
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/PACKET
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/PACKET
Approval Date
2025-04-15
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
218948
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/PACKET
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE/PACKET
Approval Date
2025-04-15
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
218948
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE/PACKET
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/PACKET
Approval Date
2025-04-15
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
219213
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/PACKET
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
10MCG
Approval Date
2024-08-02
Active Ingredient
ESTRADIOL
Application Number
216550
Product Number
1
Dosage Form
-
Strength
10MCG
Approval Date
2024-08-02
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2016-09-15
Active Ingredient
ESZOPICLONE
Application Number
208451
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2016-09-15
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2016-09-15
Active Ingredient
ESZOPICLONE
Application Number
208451
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2016-09-15
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2016-09-15
Active Ingredient
ESZOPICLONE
Application Number
208451
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2016-09-15
Regulatory Status
RX
Drug Name
ETODOLAC
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2026-07-15
Active Ingredient
ETODOLAC
Application Number
214872
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2026-07-15
Regulatory Status
RX
Drug Name
ETODOLAC
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2026-07-15
Active Ingredient
ETODOLAC
Application Number
214872
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2026-07-15
Regulatory Status
RX
Drug Name
ETYQA
Product Number
1
Dosage Form
-
Strength
0.5MG;0.1MG
Approval Date
2023-06-30
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Application Number
214729
Product Number
1
Dosage Form
-
Strength
0.5MG;0.1MG
Approval Date
2023-06-30
Regulatory Status
Discontinued
Drug Name
ETYQA
Product Number
2
Dosage Form
-
Strength
1MG;0.5MG
Approval Date
2023-06-30
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Application Number
214729
Product Number
2
Dosage Form
-
Strength
1MG;0.5MG
Approval Date
2023-06-30
Regulatory Status
Discontinued
Drug Name
EXTENDED PHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
2015-06-10
Active Ingredient
PHENYTOIN SODIUM
Application Number
204309
Product Number
1
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
2015-06-10
Regulatory Status
RX
Drug Name
EZETIMIBE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-08-25
Active Ingredient
EZETIMIBE
Application Number
209838
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-08-25
Regulatory Status
RX
Drug Name
FAMCICLOVIR
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2011-03-21
Active Ingredient
FAMCICLOVIR
Application Number
91114
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2011-03-21
Regulatory Status
RX
Drug Name
FAMCICLOVIR
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2011-03-21
Active Ingredient
FAMCICLOVIR
Application Number
91114
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2011-03-21
Regulatory Status
RX
Drug Name
FAMCICLOVIR
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2011-03-21
Active Ingredient
FAMCICLOVIR
Application Number
91114
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2011-03-21
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2015-12-22
Active Ingredient
FAMOTIDINE
Application Number
206530
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2015-12-22
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2015-12-22
Active Ingredient
FAMOTIDINE
Application Number
206530
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2015-12-22
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2016-04-26
Active Ingredient
FAMOTIDINE
Application Number
206531
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2016-04-26
Regulatory Status
OTC
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2016-04-26
Active Ingredient
FAMOTIDINE
Application Number
206531
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2016-04-26
Regulatory Status
OTC
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2025-07-09
Active Ingredient
FAMOTIDINE
Application Number
219091
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2025-07-09
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2023-10-25
Active Ingredient
FEBUXOSTAT
Application Number
210741
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2023-10-25
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2023-10-25
Active Ingredient
FEBUXOSTAT
Application Number
210741
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2023-10-25
Regulatory Status
RX
Drug Name
FELODIPINE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2013-01-17
Active Ingredient
FELODIPINE
Application Number
203417
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2013-01-17
Regulatory Status
RX
Drug Name
FELODIPINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2013-01-17
Active Ingredient
FELODIPINE
Application Number
203417
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2013-01-17
Regulatory Status
RX
Drug Name
FELODIPINE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2013-01-17
Active Ingredient
FELODIPINE
Application Number
203417
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2013-01-17
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2016-05-05
Active Ingredient
FENOFIBRATE
Application Number
205118
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2016-05-05
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2016-05-05
Active Ingredient
FENOFIBRATE
Application Number
205118
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2016-05-05
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2022-09-27
Active Ingredient
FENOFIBRATE
Application Number
216798
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2022-09-27
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2022-09-27
Active Ingredient
FENOFIBRATE
Application Number
216798
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2022-09-27
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2021-09-20
Active Ingredient
FENOFIBRATE
Application Number
212232
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2021-09-20
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2021-09-20
Active Ingredient
FENOFIBRATE
Application Number
212232
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2021-09-20
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2021-09-20
Active Ingredient
FENOFIBRATE
Application Number
212232
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2021-09-20
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2019-07-25
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
212598
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2019-07-25
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2019-07-25
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
212598
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2019-07-25
Regulatory Status
RX
Drug Name
FESOTERODINE FUMARATE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2017-02-17
Active Ingredient
FESOTERODINE FUMARATE
Application Number
205007
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2017-02-17
Regulatory Status
RX
Drug Name
FESOTERODINE FUMARATE
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2017-02-17
Active Ingredient
FESOTERODINE FUMARATE
Application Number
205007
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2017-02-17
Regulatory Status
RX
Drug Name
FEXOFENADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG/5ML
Approval Date
2023-05-23
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
213466
Product Number
1
Dosage Form
-
Strength
30MG/5ML
Approval Date
2023-05-23
Regulatory Status
OTC
Drug Name
FEXOFENADINE HYDROCHLORIDE ALLERGY
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2014-11-19
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
202039
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2014-11-19
Regulatory Status
OTC
Drug Name
FEXOFENADINE HYDROCHLORIDE ALLERGY
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
2014-11-19
Active Ingredient
FEXOFENADINE HYDROCHLORIDE
Application Number
202039
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
2014-11-19
Regulatory Status
OTC
Drug Name
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG;120MG
Approval Date
2017-10-30
Active Ingredient
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
209116
Product Number
1
Dosage Form
-
Strength
60MG;120MG
Approval Date
2017-10-30
Regulatory Status
OTC
Drug Name
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
180MG;240MG
Approval Date
2025-04-17
Active Ingredient
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
215232
Product Number
1
Dosage Form
-
Strength
180MG;240MG
Approval Date
2025-04-17
Regulatory Status
OTC
Drug Name
FINASTERIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-10-30
Active Ingredient
FINASTERIDE
Application Number
78341
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-10-30
Regulatory Status
RX
Drug Name
FINASTERIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-11-05
Active Ingredient
FINASTERIDE
Application Number
203687
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-11-05
Regulatory Status
RX
Drug Name
FINGOLIMOD HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-02-28
Active Ingredient
FINGOLIMOD HYDROCHLORIDE
Application Number
207983
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-02-28
Regulatory Status
RX
Drug Name
FLECAINIDE ACETATE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2017-11-03
Active Ingredient
FLECAINIDE ACETATE
Application Number
202821
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2017-11-03
Regulatory Status
RX
Drug Name
FLECAINIDE ACETATE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2017-11-03
Active Ingredient
FLECAINIDE ACETATE
Application Number
202821
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2017-11-03
Regulatory Status
RX
Drug Name
FLECAINIDE ACETATE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2017-11-03
Active Ingredient
FLECAINIDE ACETATE
Application Number
202821
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2017-11-03
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2008-10-07
Active Ingredient
FLUCONAZOLE
Application Number
77731
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2008-10-07
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2008-10-07
Active Ingredient
FLUCONAZOLE
Application Number
77731
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2008-10-07
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2008-10-07
Active Ingredient
FLUCONAZOLE
Application Number
77731
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2008-10-07
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2008-10-07
Active Ingredient
FLUCONAZOLE
Application Number
77731
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2008-10-07
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
2009-09-18
Active Ingredient
FLUCONAZOLE
Application Number
79150
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
2009-09-18
Regulatory Status
RX
Drug Name
FLUCONAZOLE
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2009-09-18
Active Ingredient
FLUCONAZOLE
Application Number
79150
Product Number
2
Dosage Form
-
Strength
200MG/5ML
Approval Date
2009-09-18
Regulatory Status
RX
Drug Name
FLUCYTOSINE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2020-05-01
Active Ingredient
FLUCYTOSINE
Application Number
213665
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2020-05-01
Regulatory Status
RX
Drug Name
FLUCYTOSINE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-05-01
Active Ingredient
FLUCYTOSINE
Application Number
213665
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-05-01
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-01-31
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
78619
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-01-31
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
78619
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2008-01-31
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
78619
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/5ML
Approval Date
2009-03-20
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
79209
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/5ML
Approval Date
2009-03-20
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2020-06-10
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
213265
Product Number
1
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2020-06-10
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-04-08
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
213286
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-04-08
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-04-08
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
213286
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-04-08
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2023-08-18
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218055
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2023-08-18
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2023-08-18
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218055
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2023-08-18
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2023-08-18
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218055
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2023-08-18
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2023-08-18
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218055
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2023-08-18
Regulatory Status
RX
Drug Name
FLUTICASONE PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2024-05-10
Active Ingredient
FLUTICASONE PROPIONATE
Application Number
217088
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2024-05-10
Regulatory Status
OTC
Drug Name
FOSFOMYCIN TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
EQ 3GM BASE/PACKET
Approval Date
2025-11-14
Active Ingredient
FOSFOMYCIN TROMETHAMINE
Application Number
217608
Product Number
1
Dosage Form
-
Strength
EQ 3GM BASE/PACKET
Approval Date
2025-11-14
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-03-30
Active Ingredient
FOSINOPRIL SODIUM
Application Number
91163
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-03-30
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2011-03-30
Active Ingredient
FOSINOPRIL SODIUM
Application Number
91163
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2011-03-30
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2011-03-30
Active Ingredient
FOSINOPRIL SODIUM
Application Number
91163
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2011-03-30
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2009-07-09
Active Ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Application Number
79245
Product Number
1
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2009-07-09
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2009-07-09
Active Ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Application Number
79245
Product Number
2
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2009-07-09
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-07-17
Active Ingredient
FUROSEMIDE
Application Number
218831
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-07-17
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2025-07-17
Active Ingredient
FUROSEMIDE
Application Number
218831
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2025-07-17
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2025-07-17
Active Ingredient
FUROSEMIDE
Application Number
218831
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2025-07-17
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2008-01-31
Active Ingredient
GABAPENTIN
Application Number
78787
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2008-01-31
Active Ingredient
GABAPENTIN
Application Number
78787
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2008-01-31
Active Ingredient
GABAPENTIN
Application Number
78787
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2008-01-31
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2011-10-06
Active Ingredient
GABAPENTIN
Application Number
200651
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2011-10-06
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2011-10-06
Active Ingredient
GABAPENTIN
Application Number
200651
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2011-10-06
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2011-03-29
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
90957
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2011-03-29
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2011-03-29
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
90957
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2011-03-29
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2011-03-29
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
90957
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2011-03-29
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2016-08-05
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
204895
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2016-08-05
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 16MG BASE
Approval Date
2016-08-05
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
204895
Product Number
2
Dosage Form
-
Strength
EQ 16MG BASE
Approval Date
2016-08-05
Regulatory Status
RX
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE
Approval Date
2016-08-05
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
204895
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE
Approval Date
2016-08-05
Regulatory Status
RX
Drug Name
GEMFIBROZIL
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2015-09-16
Active Ingredient
GEMFIBROZIL
Application Number
202726
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2015-09-16
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
202759
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
202759
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
202759
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIPIZIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2017-05-12
Active Ingredient
GLIPIZIDE
Application Number
206928
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
GLIPIZIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2017-05-12
Active Ingredient
GLIPIZIDE
Application Number
206928
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
GLIPIZIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2017-05-12
Active Ingredient
GLIPIZIDE
Application Number
206928
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
GLYBURIDE
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2007-10-18
Active Ingredient
GLYBURIDE
Application Number
77537
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2007-10-18
Regulatory Status
Discontinued
Drug Name
GLYBURIDE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2007-10-18
Active Ingredient
GLYBURIDE
Application Number
77537
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2007-10-18
Regulatory Status
Discontinued
Drug Name
GLYBURIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2007-10-18
Active Ingredient
GLYBURIDE
Application Number
77537
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2007-10-18
Regulatory Status
Discontinued
Drug Name
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1.25MG;250MG
Approval Date
2007-11-14
Active Ingredient
GLYBURIDE; METFORMIN HYDROCHLORIDE
Application Number
77870
Product Number
1
Dosage Form
-
Strength
1.25MG;250MG
Approval Date
2007-11-14
Regulatory Status
RX
Drug Name
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
2007-11-14
Active Ingredient
GLYBURIDE; METFORMIN HYDROCHLORIDE
Application Number
77870
Product Number
2
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
2007-11-14
Regulatory Status
RX
Drug Name
GLYBURIDE AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG;500MG
Approval Date
2007-11-14
Active Ingredient
GLYBURIDE; METFORMIN HYDROCHLORIDE
Application Number
77870
Product Number
3
Dosage Form
-
Strength
5MG;500MG
Approval Date
2007-11-14
Regulatory Status
RX
Drug Name
GLYCEROL PHENYLBUTYRATE
Product Number
1
Dosage Form
-
Strength
1.1GM/ML
Approval Date
2026-04-15
Active Ingredient
GLYCEROL PHENYLBUTYRATE
Application Number
220313
Product Number
1
Dosage Form
-
Strength
1.1GM/ML
Approval Date
2026-04-15
Regulatory Status
RX
Drug Name
GLYCEROL PHENYLBUTYRATE
Product Number
2
Dosage Form
-
Strength
1.1G/1ML
Approval Date
-
Active Ingredient
GLYCEROL PHENYLBUTYRATE
Application Number
220313
Product Number
2
Dosage Form
-
Strength
1.1G/1ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
GLYCEROL PHENYLBUTYRATE
Product Number
3
Dosage Form
-
Strength
450ML
Approval Date
-
Active Ingredient
GLYCEROL PHENYLBUTYRATE
Application Number
220313
Product Number
3
Dosage Form
-
Strength
450ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-04-15
Active Ingredient
GLYCOPYRROLATE
Application Number
202675
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-04-15
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2018-10-30
Active Ingredient
GLYCOPYRROLATE
Application Number
202675
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2018-10-30
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
2024-12-31
Active Ingredient
GLYCOPYRROLATE
Application Number
214847
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
2024-12-31
Regulatory Status
RX
Drug Name
GUAIFENESIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2019-10-21
Active Ingredient
GUAIFENESIN
Application Number
210453
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2019-10-21
Regulatory Status
OTC
Drug Name
GUAIFENESIN
Product Number
2
Dosage Form
-
Strength
1.2GM
Approval Date
2019-10-21
Active Ingredient
GUAIFENESIN
Application Number
210453
Product Number
2
Dosage Form
-
Strength
1.2GM
Approval Date
2019-10-21
Regulatory Status
OTC
Drug Name
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
30MG;600MG
Approval Date
2017-03-17
Active Ingredient
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Application Number
206941
Product Number
1
Dosage Form
-
Strength
30MG;600MG
Approval Date
2017-03-17
Regulatory Status
OTC
Drug Name
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
60MG;1.2GM
Approval Date
2017-03-17
Active Ingredient
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Application Number
206941
Product Number
2
Dosage Form
-
Strength
60MG;1.2GM
Approval Date
2017-03-17
Regulatory Status
OTC
Drug Name
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
600MG;60MG
Approval Date
2020-03-25
Active Ingredient
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
213203
Product Number
1
Dosage Form
-
Strength
600MG;60MG
Approval Date
2020-03-25
Regulatory Status
OTC
Drug Name
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1.2GM;120MG
Approval Date
2020-03-25
Active Ingredient
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
213203
Product Number
2
Dosage Form
-
Strength
1.2GM;120MG
Approval Date
2020-03-25
Regulatory Status
OTC
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2024-04-19
Active Ingredient
HALOPERIDOL
Application Number
218789
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2024-04-19
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2024-04-19
Active Ingredient
HALOPERIDOL
Application Number
218789
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2024-04-19
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2024-04-19
Active Ingredient
HALOPERIDOL
Application Number
218789
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2024-04-19
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2024-04-19
Active Ingredient
HALOPERIDOL
Application Number
218789
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2024-04-19
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2024-04-19
Active Ingredient
HALOPERIDOL
Application Number
218789
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2024-04-19
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2024-04-19
Active Ingredient
HALOPERIDOL
Application Number
218789
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2024-04-19
Regulatory Status
RX
Drug Name
HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2007-07-20
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
40780
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2007-07-20
Regulatory Status
RX
Drug Name
HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2007-07-20
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
40780
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2007-07-20
Regulatory Status
RX
Drug Name
HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2007-09-18
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
78164
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2007-09-18
Regulatory Status
RX
Drug Name
HYDROCORTISONE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-07-17
Active Ingredient
HYDROCORTISONE
Application Number
214649
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-07-17
Regulatory Status
RX
Drug Name
HYDROCORTISONE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2023-07-17
Active Ingredient
HYDROCORTISONE
Application Number
214649
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2023-07-17
Regulatory Status
RX
Drug Name
HYDROCORTISONE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2023-07-17
Active Ingredient
HYDROCORTISONE
Application Number
214649
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2023-07-17
Regulatory Status
RX
Drug Name
HYDROXYZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-12-20
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
87871
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-12-20
Regulatory Status
RX
Drug Name
HYDROXYZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-12-20
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
87871
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1982-12-20
Regulatory Status
RX
Drug Name
HYDROXYZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-12-20
Active Ingredient
HYDROXYZINE HYDROCHLORIDE
Application Number
87871
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1982-12-20
Regulatory Status
RX
Drug Name
IBANDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2016-03-11
Active Ingredient
IBANDRONATE SODIUM
Application Number
204502
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2016-03-11
Regulatory Status
RX
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2018-06-29
Active Ingredient
IBUPROFEN
Application Number
207753
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2018-06-29
Regulatory Status
OTC
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2017-11-08
Active Ingredient
IBUPROFEN
Application Number
208865
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2017-11-08
Regulatory Status
OTC
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2018-02-16
Active Ingredient
IBUPROFEN
Application Number
209178
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2018-02-16
Regulatory Status
RX
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2018-04-17
Active Ingredient
IBUPROFEN
Application Number
209179
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2018-04-17
Regulatory Status
OTC
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2024-04-08
Active Ingredient
IBUPROFEN
Application Number
213506
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2024-04-08
Regulatory Status
OTC
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2020-05-08
Active Ingredient
IBUPROFEN
Application Number
213794
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2020-05-08
Regulatory Status
RX
Drug Name
IBUPROFEN
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
2020-05-08
Active Ingredient
IBUPROFEN
Application Number
213794
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
2020-05-08
Regulatory Status
RX
Drug Name
IBUPROFEN
Product Number
3
Dosage Form
-
Strength
800MG
Approval Date
2020-05-08
Active Ingredient
IBUPROFEN
Application Number
213794
Product Number
3
Dosage Form
-
Strength
800MG
Approval Date
2020-05-08
Regulatory Status
RX
Drug Name
IBUPROFEN
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2023-09-14
Active Ingredient
IBUPROFEN
Application Number
215777
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2023-09-14
Regulatory Status
OTC
Drug Name
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
Product Number
1
Dosage Form
-
Strength
38MG;200MG
Approval Date
2022-05-31
Active Ingredient
DIPHENHYDRAMINE CITRATE; IBUPROFEN
Application Number
216204
Product Number
1
Dosage Form
-
Strength
38MG;200MG
Approval Date
2022-05-31
Regulatory Status
OTC
Drug Name
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2019-02-14
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Application Number
210676
Product Number
1
Dosage Form
-
Strength
25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date
2019-02-14
Regulatory Status
OTC
Drug Name
IBUPROFEN AND FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
26.6MG;800MG
Approval Date
2025-06-30
Active Ingredient
FAMOTIDINE; IBUPROFEN
Application Number
219538
Product Number
1
Dosage Form
-
Strength
26.6MG;800MG
Approval Date
2025-06-30
Regulatory Status
Discontinued
Drug Name
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Approval Date
2017-12-01
Active Ingredient
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
209235
Product Number
1
Dosage Form
-
Strength
EQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Approval Date
2017-12-01
Regulatory Status
OTC
Drug Name
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG;30MG
Approval Date
2023-03-10
Active Ingredient
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
213565
Product Number
1
Dosage Form
-
Strength
200MG;30MG
Approval Date
2023-03-10
Regulatory Status
OTC
Drug Name
ICLEVIA
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2018-06-29
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
206850
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2018-06-29
Regulatory Status
RX
Drug Name
ICOSAPENT ETHYL
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2026-06-24
Active Ingredient
ICOSAPENT ETHYL
Application Number
218949
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2026-06-24
Regulatory Status
RX
Drug Name
INCASSIA
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2016-09-23
Active Ingredient
NORETHINDRONE
Application Number
207304
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2016-09-23
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2016-12-27
Active Ingredient
INDOMETHACIN
Application Number
204243
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2016-12-27
Regulatory Status
Discontinued
Drug Name
IRBESARTAN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-09-27
Active Ingredient
IRBESARTAN
Application Number
203081
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-09-27
Active Ingredient
IRBESARTAN
Application Number
203081
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-09-27
Active Ingredient
IRBESARTAN
Application Number
203081
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2013-02-22
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
203630
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2013-02-22
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2013-02-22
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
203630
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2013-02-22
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;300MG
Approval Date
2016-03-31
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
203630
Product Number
3
Dosage Form
-
Strength
25MG;300MG
Approval Date
2016-03-31
Regulatory Status
RX
Drug Name
ISOSORBIDE MONONITRATE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2022-11-07
Active Ingredient
ISOSORBIDE MONONITRATE
Application Number
216557
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2022-11-07
Regulatory Status
RX
Drug Name
ISOSORBIDE MONONITRATE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2022-11-07
Active Ingredient
ISOSORBIDE MONONITRATE
Application Number
216557
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2022-11-07
Regulatory Status
RX
Drug Name
ISOSORBIDE MONONITRATE
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
2022-11-07
Active Ingredient
ISOSORBIDE MONONITRATE
Application Number
216557
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
2022-11-07
Regulatory Status
RX
Drug Name
ISOTRETINOIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-01-29
Active Ingredient
ISOTRETINOIN
Application Number
218194
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-01-29
Regulatory Status
RX
Drug Name
ISOTRETINOIN
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-01-29
Active Ingredient
ISOTRETINOIN
Application Number
218194
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-01-29
Regulatory Status
RX
Drug Name
ISOTRETINOIN
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
2024-01-29
Active Ingredient
ISOTRETINOIN
Application Number
218194
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
2024-01-29
Regulatory Status
RX
Drug Name
ISOTRETINOIN
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2024-01-29
Active Ingredient
ISOTRETINOIN
Application Number
218194
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2024-01-29
Regulatory Status
RX
Drug Name
ISOTRETINOIN
Product Number
5
Dosage Form
-
Strength
35MG
Approval Date
2024-01-29
Active Ingredient
ISOTRETINOIN
Application Number
218194
Product Number
5
Dosage Form
-
Strength
35MG
Approval Date
2024-01-29
Regulatory Status
RX
Drug Name
ISOTRETINOIN
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2024-01-29
Active Ingredient
ISOTRETINOIN
Application Number
218194
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2024-01-29
Regulatory Status
RX
Drug Name
KALLIGA
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG
Approval Date
2017-05-17
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
207081
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG
Approval Date
2017-05-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2023-01-05
Active Ingredient
LACOSAMIDE
Application Number
204994
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2023-01-05
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2023-01-05
Active Ingredient
LACOSAMIDE
Application Number
204994
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2023-01-05
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2023-01-05
Active Ingredient
LACOSAMIDE
Application Number
204994
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2023-01-05
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2023-01-05
Active Ingredient
LACOSAMIDE
Application Number
204994
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2023-01-05
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2024-01-24
Active Ingredient
LACOSAMIDE
Application Number
209224
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2024-01-24
Regulatory Status
RX
Drug Name
LACTULOSE
Product Number
1
Dosage Form
-
Strength
10GM/15ML
Approval Date
1996-11-14
Active Ingredient
LACTULOSE
Application Number
74602
Product Number
1
Dosage Form
-
Strength
10GM/15ML
Approval Date
1996-11-14
Regulatory Status
RX
Drug Name
LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2016-11-21
Active Ingredient
LAMIVUDINE
Application Number
77464
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2016-11-21
Regulatory Status
RX
Drug Name
LAMIVUDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2016-11-21
Active Ingredient
LAMIVUDINE
Application Number
77464
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2016-11-21
Regulatory Status
RX
Drug Name
LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2016-11-21
Active Ingredient
LAMIVUDINE
Application Number
77695
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2016-11-21
Regulatory Status
RX
Drug Name
LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2011-11-17
Active Ingredient
LAMIVUDINE
Application Number
202032
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2011-11-17
Regulatory Status
Discontinued
Drug Name
LAMIVUDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2011-11-17
Active Ingredient
LAMIVUDINE
Application Number
202032
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2011-11-17
Regulatory Status
Discontinued
Drug Name
LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
300MG;300MG
Approval Date
2018-05-15
Active Ingredient
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
22344
Product Number
1
Dosage Form
-
Strength
300MG;300MG
Approval Date
2018-05-15
Regulatory Status
Discontinued
Drug Name
LAMIVUDINE AND ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
150MG;300MG
Approval Date
2017-05-05
Active Ingredient
LAMIVUDINE; ZIDOVUDINE
Application Number
77558
Product Number
1
Dosage Form
-
Strength
150MG;300MG
Approval Date
2017-05-05
Regulatory Status
RX
Drug Name
LAMIVUDINE AND ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
150MG;300MG
Approval Date
2012-05-15
Active Ingredient
LAMIVUDINE; ZIDOVUDINE
Application Number
202418
Product Number
1
Dosage Form
-
Strength
150MG;300MG
Approval Date
2012-05-15
Regulatory Status
Discontinued
Drug Name
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
300MG; 300MG; 200MG
Approval Date
-
Active Ingredient
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE; NEVIRAPINE
Application Number
204505
Product Number
1
Dosage Form
-
Strength
300MG; 300MG; 200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
150MG; 300MG; 600MG
Approval Date
-
Active Ingredient
LAMIVUDINE; ZIDOVUDINE; EFAVIRENZ
Application Number
21943
Product Number
1
Dosage Form
-
Strength
150MG; 300MG; 600MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Active Ingredient
LAMIVUDINE; ZIDOVUDINE
Application Number
22296
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; ZIDOVUDINE; ABACAVIR
Product Number
1
Dosage Form
-
Strength
150MG; 300MG; 300MG
Approval Date
-
Active Ingredient
LAMIVUDINE; ZIDOVUDINE; ABACAVIR
Application Number
21944
Product Number
1
Dosage Form
-
Strength
150MG; 300MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-01-27
Active Ingredient
LAMOTRIGINE
Application Number
78956
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-01-27
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2009-01-27
Active Ingredient
LAMOTRIGINE
Application Number
78956
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2009-01-27
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2009-01-27
Active Ingredient
LAMOTRIGINE
Application Number
78956
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2009-01-27
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-01-27
Active Ingredient
LAMOTRIGINE
Application Number
78956
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-01-27
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
LAMOTRIGINE
Application Number
90401
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2009-11-04
Active Ingredient
LAMOTRIGINE
Application Number
90401
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2009-11-04
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
2009-11-04
Active Ingredient
LAMOTRIGINE
Application Number
90401
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
2009-11-04
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2023-03-28
Active Ingredient
LANSOPRAZOLE
Application Number
207167
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2023-03-28
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2023-03-28
Active Ingredient
LANSOPRAZOLE
Application Number
207167
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2023-03-28
Regulatory Status
RX
Drug Name
LEFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-03-29
Active Ingredient
LEFLUNOMIDE
Application Number
213652
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-03-29
Regulatory Status
RX
Drug Name
LEFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-03-29
Active Ingredient
LEFLUNOMIDE
Application Number
213652
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-03-29
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78993
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78993
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78993
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78993
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
79063
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
201043
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-06-20
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
201043
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2011-06-20
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
201043
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2011-06-20
Regulatory Status
RX
Drug Name
LEVOMILNACIPRAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2023-01-06
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
210826
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2023-01-06
Regulatory Status
Discontinued
Drug Name
LEVOMILNACIPRAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2023-01-06
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
210826
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2023-01-06
Regulatory Status
Discontinued
Drug Name
LEVOMILNACIPRAN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2023-01-06
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
210826
Product Number
3
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2023-01-06
Regulatory Status
Discontinued
Drug Name
LEVOMILNACIPRAN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 120MG BASE
Approval Date
2023-01-06
Active Ingredient
LEVOMILNACIPRAN HYDROCHLORIDE
Application Number
210826
Product Number
4
Dosage Form
-
Strength
EQ 120MG BASE
Approval Date
2023-01-06
Regulatory Status
Discontinued
Drug Name
LEVOTHYROXINE SODIUM
Product Number
1
Dosage Form
-
Strength
0.137MG
Approval Date
2024-07-16
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216414
Product Number
1
Dosage Form
-
Strength
0.137MG
Approval Date
2024-07-16
Regulatory Status
Discontinued
Drug Name
LEVOTHYROXINE SODIUM
Product Number
2
Dosage Form
-
Strength
0.15MG
Approval Date
2024-07-16
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216414
Product Number
2
Dosage Form
-
Strength
0.15MG
Approval Date
2024-07-16
Regulatory Status
Discontinued
Drug Name
LEVOTHYROXINE SODIUM
Product Number
3
Dosage Form
-
Strength
0.175MG
Approval Date
2024-07-16
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216414
Product Number
3
Dosage Form
-
Strength
0.175MG
Approval Date
2024-07-16
Regulatory Status
Discontinued
Drug Name
LEVOTHYROXINE SODIUM
Product Number
4
Dosage Form
-
Strength
0.2MG
Approval Date
2024-07-16
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216414
Product Number
4
Dosage Form
-
Strength
0.2MG
Approval Date
2024-07-16
Regulatory Status
Discontinued
Drug Name
LEVOTHYROXINE SODIUM
Product Number
5
Dosage Form
-
Strength
0.3MG
Approval Date
2024-07-16
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216414
Product Number
5
Dosage Form
-
Strength
0.3MG
Approval Date
2024-07-16
Regulatory Status
Discontinued
Drug Name
LIDOCAINE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2024-06-18
Active Ingredient
LIDOCAINE
Application Number
217117
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2024-06-18
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
2025-07-29
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
219759
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
2025-07-29
Regulatory Status
RX
Drug Name
LINACLOTIDE
Product Number
1
Dosage Form
-
Strength
145MCG
Approval Date
2023-02-07
Active Ingredient
LINACLOTIDE
Application Number
209611
Product Number
1
Dosage Form
-
Strength
145MCG
Approval Date
2023-02-07
Regulatory Status
Discontinued
Drug Name
LINACLOTIDE
Product Number
2
Dosage Form
-
Strength
290MCG
Approval Date
2023-02-07
Active Ingredient
LINACLOTIDE
Application Number
209611
Product Number
2
Dosage Form
-
Strength
290MCG
Approval Date
2023-02-07
Regulatory Status
Discontinued
Drug Name
LINAGLIPTIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN
Application Number
208415
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2006-02-22
Active Ingredient
LISINOPRIL
Application Number
77622
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2006-02-22
Active Ingredient
LISINOPRIL
Application Number
77622
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2006-02-22
Active Ingredient
LISINOPRIL
Application Number
77622
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2006-02-22
Active Ingredient
LISINOPRIL
Application Number
77622
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2006-02-22
Active Ingredient
LISINOPRIL
Application Number
77622
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2006-02-22
Active Ingredient
LISINOPRIL
Application Number
77622
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2006-02-22
Regulatory Status
RX
Drug Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;10MG
Approval Date
2006-03-14
Active Ingredient
HYDROCHLOROTHIAZIDE; LISINOPRIL
Application Number
77606
Product Number
1
Dosage Form
-
Strength
12.5MG;10MG
Approval Date
2006-03-14
Regulatory Status
RX
Drug Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2006-03-14
Active Ingredient
HYDROCHLOROTHIAZIDE; LISINOPRIL
Application Number
77606
Product Number
2
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2006-03-14
Regulatory Status
RX
Drug Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;20MG
Approval Date
2006-03-14
Active Ingredient
HYDROCHLOROTHIAZIDE; LISINOPRIL
Application Number
77606
Product Number
3
Dosage Form
-
Strength
25MG;20MG
Approval Date
2006-03-14
Regulatory Status
RX
Drug Name
LO SIMPESSE
Product Number
1
Dosage Form
-
Strength
0.02MG,0.1MG;0.01MG,N/A
Approval Date
2017-04-28
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
206852
Product Number
1
Dosage Form
-
Strength
0.02MG,0.1MG;0.01MG,N/A
Approval Date
2017-04-28
Regulatory Status
RX
Drug Name
LO-ZUMANDIMINE
Product Number
1
Dosage Form
-
Strength
3MG;0.02MG
Approval Date
2018-02-27
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
209632
Product Number
1
Dosage Form
-
Strength
3MG;0.02MG
Approval Date
2018-02-27
Regulatory Status
RX
Drug Name
LOPERAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-12-15
Active Ingredient
LOPERAMIDE HYDROCHLORIDE
Application Number
206548
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-12-15
Regulatory Status
OTC
Drug Name
LOPERAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2023-09-05
Active Ingredient
LOPERAMIDE HYDROCHLORIDE
Application Number
218122
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2023-09-05
Regulatory Status
RX
Drug Name
LOPERAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2025-12-29
Active Ingredient
LOPERAMIDE HYDROCHLORIDE
Application Number
220372
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2025-12-29
Regulatory Status
OTC
Drug Name
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
Product Number
1
Dosage Form
-
Strength
2MG;125MG
Approval Date
2020-12-14
Active Ingredient
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
Application Number
211059
Product Number
1
Dosage Form
-
Strength
2MG;125MG
Approval Date
2020-12-14
Regulatory Status
OTC
Drug Name
LOPINAVIR; RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG; 25MG
Approval Date
-
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
90471
Product Number
1
Dosage Form
-
Strength
100MG; 25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LOPINAVIR; RITONAVIR
Product Number
2
Dosage Form
-
Strength
200MG; 50MG
Approval Date
-
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
90471
Product Number
2
Dosage Form
-
Strength
200MG; 50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LORATADINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-04-16
Active Ingredient
LORATADINE
Application Number
208314
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-04-16
Regulatory Status
OTC
Drug Name
LORATADINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-04-11
Active Ingredient
LORATADINE
Application Number
208477
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-04-11
Regulatory Status
OTC
Drug Name
LORATADINE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2018-06-29
Active Ingredient
LORATADINE
Application Number
208931
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2018-06-29
Regulatory Status
OTC
Drug Name
LORATADINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-03-24
Active Ingredient
LORATADINE
Application Number
211900
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-03-24
Regulatory Status
OTC
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2017-12-22
Active Ingredient
LORAZEPAM
Application Number
203572
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2017-12-22
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2017-12-22
Active Ingredient
LORAZEPAM
Application Number
203572
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2017-12-22
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2017-12-22
Active Ingredient
LORAZEPAM
Application Number
203572
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2017-12-22
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90083
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90083
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90083
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2010-10-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91629
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-10-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91629
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-01-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91629
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-01-06
Regulatory Status
RX
Drug Name
LUMATEPERONE
Product Number
1
Dosage Form
-
Strength
42MG
Approval Date
-
Active Ingredient
LUMATEPERONE
Application Number
219085
Product Number
1
Dosage Form
-
Strength
42MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LUMATEPERONE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
-
Active Ingredient
LUMATEPERONE
Application Number
219085
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LUMATEPERONE
Product Number
3
Dosage Form
-
Strength
28MG
Approval Date
-
Active Ingredient
LUMATEPERONE
Application Number
219085
Product Number
3
Dosage Form
-
Strength
28MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LUMATEPERONE
Product Number
4
Dosage Form
-
Strength
10.5MG
Approval Date
-
Active Ingredient
LUMATEPERONE
Application Number
219085
Product Number
4
Dosage Form
-
Strength
10.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LUMATEPERONE
Product Number
5
Dosage Form
-
Strength
21MG
Approval Date
-
Active Ingredient
LUMATEPERONE
Application Number
219085
Product Number
5
Dosage Form
-
Strength
21MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-03-10
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208045
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-03-10
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2023-03-10
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208045
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2023-03-10
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2023-03-10
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208045
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2023-03-10
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2023-03-10
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208045
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2023-03-10
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2023-03-10
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208045
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2023-03-10
Regulatory Status
RX
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-04-18
Active Ingredient
MACITENTAN
Application Number
211198
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-04-18
Regulatory Status
RX
Drug Name
MELOXICAM
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2006-10-02
Active Ingredient
MELOXICAM
Application Number
78008
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2006-10-02
Regulatory Status
RX
Drug Name
MELOXICAM
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2006-10-02
Active Ingredient
MELOXICAM
Application Number
78008
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2006-10-02
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-10-13
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
203175
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-10-13
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
203175
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2021-08-09
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
214651
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2021-08-09
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2021-08-09
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
214651
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2021-08-09
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
21MG
Approval Date
2021-08-09
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
214651
Product Number
3
Dosage Form
-
Strength
21MG
Approval Date
2021-08-09
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
28MG
Approval Date
2021-08-09
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
214651
Product Number
4
Dosage Form
-
Strength
28MG
Approval Date
2021-08-09
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2023-03-31
Active Ingredient
MESALAMINE
Application Number
214477
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2023-03-31
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-01-14
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
77095
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2005-01-14
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2005-01-14
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
77095
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2005-01-14
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2005-01-14
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
77095
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2005-01-14
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-07-20
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
79118
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-07-20
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2012-07-20
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
79118
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2012-07-20
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2024-10-18
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
209694
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2024-10-18
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2024-10-18
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
209694
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2024-10-18
Regulatory Status
RX
Drug Name
METHENAMINE HIPPURATE
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2016-07-05
Active Ingredient
METHENAMINE HIPPURATE
Application Number
205661
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2016-07-05
Regulatory Status
RX
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2020-08-12
Active Ingredient
METHOCARBAMOL
Application Number
213967
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2020-08-12
Regulatory Status
RX
Drug Name
METHOCARBAMOL
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2023-02-09
Active Ingredient
METHOCARBAMOL
Application Number
213967
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2023-02-09
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2007-09-11
Active Ingredient
METOPROLOL TARTRATE
Application Number
77739
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2007-09-11
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2007-09-11
Active Ingredient
METOPROLOL TARTRATE
Application Number
77739
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2007-09-11
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2007-09-11
Active Ingredient
METOPROLOL TARTRATE
Application Number
77739
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2007-09-11
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
4
Dosage Form
-
Strength
37.5MG
Approval Date
2023-12-07
Active Ingredient
METOPROLOL TARTRATE
Application Number
77739
Product Number
4
Dosage Form
-
Strength
37.5MG
Approval Date
2023-12-07
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2023-12-07
Active Ingredient
METOPROLOL TARTRATE
Application Number
77739
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2023-12-07
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2015-05-29
Active Ingredient
METRONIDAZOLE
Application Number
203974
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2015-05-29
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2015-05-29
Active Ingredient
METRONIDAZOLE
Application Number
203974
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2015-05-29
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2024-10-15
Active Ingredient
METRONIDAZOLE
Application Number
218941
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2024-10-15
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
0.75%
Approval Date
2025-07-09
Active Ingredient
METRONIDAZOLE
Application Number
219295
Product Number
1
Dosage Form
-
Strength
0.75%
Approval Date
2025-07-09
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-08-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
212774
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-08-10
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-08-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
212774
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-08-10
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2020-08-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
212774
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2020-08-10
Regulatory Status
RX
Drug Name
MILI
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG
Approval Date
2016-07-07
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
205449
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG
Approval Date
2016-07-07
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2008-03-11
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65470
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2008-03-11
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2008-03-11
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65470
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2008-03-11
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2008-03-11
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65470
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2008-03-11
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2012-11-19
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
1
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2012-11-19
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 65MG BASE
Approval Date
2018-09-28
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
2
Dosage Form
-
Strength
EQ 65MG BASE
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2012-11-19
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
3
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2012-11-19
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 115MG BASE
Approval Date
2018-09-28
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
4
Dosage Form
-
Strength
EQ 115MG BASE
Approval Date
2018-09-28
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 135MG BASE
Approval Date
2012-11-19
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
5
Dosage Form
-
Strength
EQ 135MG BASE
Approval Date
2012-11-19
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2016-06-13
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
6
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2016-06-13
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
EQ 105MG BASE
Approval Date
2016-06-13
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
7
Dosage Form
-
Strength
EQ 105MG BASE
Approval Date
2016-06-13
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
8
Dosage Form
-
Strength
EQ 55MG BASE
Approval Date
2019-08-21
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
202261
Product Number
8
Dosage Form
-
Strength
EQ 55MG BASE
Approval Date
2019-08-21
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2020-05-01
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
213662
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2020-05-01
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-05-01
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
213662
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-05-01
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-05-01
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
213662
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-05-01
Regulatory Status
RX
Drug Name
MINOXIDIL (FOR MEN)
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1997-02-28
Active Ingredient
MINOXIDIL
Application Number
74767
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1997-02-28
Regulatory Status
OTC
Drug Name
MINOXIDIL (FOR MEN)
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2024-04-22
Active Ingredient
MINOXIDIL
Application Number
218616
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2024-04-22
Regulatory Status
OTC
Drug Name
MINOXIDIL (FOR WOMEN)
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
1997-11-25
Active Ingredient
MINOXIDIL
Application Number
74767
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
1997-11-25
Regulatory Status
OTC
Drug Name
MINOXIDIL (FOR WOMEN)
Product Number
2
Dosage Form
-
Strength
5%
Approval Date
2024-04-22
Active Ingredient
MINOXIDIL
Application Number
218616
Product Number
2
Dosage Form
-
Strength
5%
Approval Date
2024-04-22
Regulatory Status
OTC
Drug Name
MINOXIDIL EXTRA STRENGTH (FOR MEN)
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2003-02-27
Active Ingredient
MINOXIDIL
Application Number
75438
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2003-02-27
Regulatory Status
OTC
Drug Name
MIRABEGRON
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
MIRABEGRON
Application Number
209413
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MIRTAZAPINE
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2004-10-22
Active Ingredient
MIRTAZAPINE
Application Number
76921
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2004-10-22
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2004-10-22
Active Ingredient
MIRTAZAPINE
Application Number
76921
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2004-10-22
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2004-10-22
Active Ingredient
MIRTAZAPINE
Application Number
76921
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2004-10-22
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2004-10-22
Active Ingredient
MIRTAZAPINE
Application Number
76921
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2004-10-22
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2005-12-08
Active Ingredient
MIRTAZAPINE
Application Number
77376
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2005-12-08
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2005-12-08
Active Ingredient
MIRTAZAPINE
Application Number
77376
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2005-12-08
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2006-02-28
Active Ingredient
MIRTAZAPINE
Application Number
77376
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2006-02-28
Regulatory Status
RX
Drug Name
MODAFINIL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-09-27
Active Ingredient
MODAFINIL
Application Number
202566
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
MODAFINIL
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2012-09-27
Active Ingredient
MODAFINIL
Application Number
202566
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
MOMETASONE FUROATE
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2024-03-18
Active Ingredient
MOMETASONE FUROATE
Application Number
215878
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2024-03-18
Regulatory Status
RX
Drug Name
MOMETASONE FUROATE
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2024-11-22
Active Ingredient
MOMETASONE FUROATE
Application Number
217498
Product Number
1
Dosage Form
-
Strength
0.05MG/SPRAY
Approval Date
2024-11-22
Regulatory Status
Discontinued
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2012-08-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
202096
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2012-08-03
Regulatory Status
RX
Drug Name
MONTELUKAST SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-08-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
202096
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-08-03
Regulatory Status
RX
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-08-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
202468
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-08-03
Regulatory Status
RX
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/PACKET
Approval Date
2020-02-18
Active Ingredient
MONTELUKAST SODIUM
Application Number
213471
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/PACKET
Approval Date
2020-02-18
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2014-03-04
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
202632
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2014-03-04
Regulatory Status
RX
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2024-01-05
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
217828
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2024-01-05
Regulatory Status
RX
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2024-02-20
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
217937
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2024-02-20
Regulatory Status
RX
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2024-09-26
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
218227
Product Number
1
Dosage Form
-
Strength
200MG/ML
Approval Date
2024-09-26
Regulatory Status
RX
Drug Name
MYCOPHENOLATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 180MG BASE
Approval Date
2024-02-27
Active Ingredient
MYCOPHENOLATE SODIUM
Application Number
218603
Product Number
1
Dosage Form
-
Strength
EQ 180MG BASE
Approval Date
2024-02-27
Regulatory Status
RX
Drug Name
MYCOPHENOLATE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 360MG BASE
Approval Date
2024-02-27
Active Ingredient
MYCOPHENOLATE SODIUM
Application Number
218603
Product Number
2
Dosage Form
-
Strength
EQ 360MG BASE
Approval Date
2024-02-27
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-09-16
Active Ingredient
NADOLOL
Application Number
201893
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-09-16
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-09-16
Active Ingredient
NADOLOL
Application Number
201893
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-09-16
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2022-06-07
Active Ingredient
NADOLOL
Application Number
201893
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2022-06-07
Regulatory Status
RX
Drug Name
NAPROXEN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-11-08
Active Ingredient
NAPROXEN
Application Number
200429
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-11-08
Regulatory Status
RX
Drug Name
NAPROXEN
Product Number
2
Dosage Form
-
Strength
375MG
Approval Date
2011-11-08
Active Ingredient
NAPROXEN
Application Number
200429
Product Number
2
Dosage Form
-
Strength
375MG
Approval Date
2011-11-08
Regulatory Status
RX
Drug Name
NAPROXEN
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2011-11-08
Active Ingredient
NAPROXEN
Application Number
200429
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2011-11-08
Regulatory Status
RX
Drug Name
NAPROXEN
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2025-10-03
Active Ingredient
NAPROXEN
Application Number
216504
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2025-10-03
Regulatory Status
Discontinued
Drug Name
NAPROXEN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2011-10-31
Active Ingredient
NAPROXEN SODIUM
Application Number
200629
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2011-10-31
Regulatory Status
RX
Drug Name
NAPROXEN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2011-10-31
Active Ingredient
NAPROXEN SODIUM
Application Number
200629
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2011-10-31
Regulatory Status
RX
Drug Name
NAPROXEN SODIUM
Product Number
1
Dosage Form
-
Strength
220MG
Approval Date
2016-03-18
Active Ingredient
NAPROXEN SODIUM
Application Number
205497
Product Number
1
Dosage Form
-
Strength
220MG
Approval Date
2016-03-18
Regulatory Status
OTC
Drug Name
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
220MG;120MG
Approval Date
2022-06-01
Active Ingredient
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
211360
Product Number
1
Dosage Form
-
Strength
220MG;120MG
Approval Date
2022-06-01
Regulatory Status
OTC
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2021-12-17
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
211053
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2021-12-17
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2021-12-17
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
211053
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2021-12-17
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2021-12-17
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
211053
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2021-12-17
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2021-12-17
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
211053
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2021-12-17
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Active Ingredient
NEVIRAPINE
Application Number
77521
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
2012-05-22
Active Ingredient
NEVIRAPINE
Application Number
77702
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
2012-05-22
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2017-02-28
Active Ingredient
NEVIRAPINE
Application Number
207698
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2017-02-28
Regulatory Status
Discontinued
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2016-11-23
Active Ingredient
NEVIRAPINE
Application Number
208616
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2016-11-23
Regulatory Status
Discontinued
Drug Name
NEVIRAPINE TABLETS FOR ORAL SUSPENSION
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
NEVIRAPINE
Application Number
22299
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NEXESTA FE
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2017-02-02
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
207535
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2017-02-02
Regulatory Status
RX
Drug Name
NIACIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2018-02-01
Active Ingredient
NIACIN
Application Number
209236
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2018-02-01
Regulatory Status
RX
Drug Name
NIACIN
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2018-02-01
Active Ingredient
NIACIN
Application Number
209236
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2018-02-01
Regulatory Status
RX
Drug Name
NIACIN
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2018-02-01
Active Ingredient
NIACIN
Application Number
209236
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2018-02-01
Regulatory Status
RX
Drug Name
NICOTINE POLACRILEX
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2021-08-03
Active Ingredient
NICOTINE POLACRILEX
Application Number
213266
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2021-08-03
Regulatory Status
OTC
Drug Name
NICOTINE POLACRILEX
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2021-08-03
Active Ingredient
NICOTINE POLACRILEX
Application Number
213266
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2021-08-03
Regulatory Status
OTC
Drug Name
NICOTINE POLACRILEX
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2022-05-13
Active Ingredient
NICOTINE POLACRILEX
Application Number
215357
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2022-05-13
Regulatory Status
OTC
Drug Name
NICOTINE POLACRILEX
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2022-05-13
Active Ingredient
NICOTINE POLACRILEX
Application Number
215357
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2022-05-13
Regulatory Status
OTC
Drug Name
NIFEDIPINE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2021-07-19
Active Ingredient
NIFEDIPINE
Application Number
213361
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2021-07-19
Regulatory Status
RX
Drug Name
NIFEDIPINE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2021-07-19
Active Ingredient
NIFEDIPINE
Application Number
213361
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2021-07-19
Regulatory Status
RX
Drug Name
NIFEDIPINE
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2021-07-19
Active Ingredient
NIFEDIPINE
Application Number
213361
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2021-07-19
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
1
Dosage Form
-
Strength
25MG/5ML
Approval Date
2023-05-11
Active Ingredient
NITROFURANTOIN
Application Number
212607
Product Number
1
Dosage Form
-
Strength
25MG/5ML
Approval Date
2023-05-11
Regulatory Status
RX
Drug Name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Product Number
1
Dosage Form
-
Strength
75MG;25MG
Approval Date
2023-03-30
Active Ingredient
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Application Number
209225
Product Number
1
Dosage Form
-
Strength
75MG;25MG
Approval Date
2023-03-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2023-10-26
Active Ingredient
NITROGLYCERIN
Application Number
217879
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2023-10-26
Active Ingredient
NITROGLYCERIN
Application Number
217879
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2023-10-26
Active Ingredient
NITROGLYCERIN
Application Number
217879
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
NORETHINDRONE ACETATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2016-01-08
Active Ingredient
NORETHINDRONE ACETATE
Application Number
204236
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2016-01-08
Regulatory Status
Discontinued
Drug Name
NORTRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1997-06-30
Active Ingredient
NORTRIPTYLINE HYDROCHLORIDE
Application Number
74835
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1997-06-30
Regulatory Status
Discontinued
Drug Name
NORTRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1997-06-30
Active Ingredient
NORTRIPTYLINE HYDROCHLORIDE
Application Number
74835
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1997-06-30
Regulatory Status
Discontinued
Drug Name
NORTRIPTYLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1997-06-30
Active Ingredient
NORTRIPTYLINE HYDROCHLORIDE
Application Number
74835
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1997-06-30
Regulatory Status
Discontinued
Drug Name
NORTRIPTYLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1997-06-30
Active Ingredient
NORTRIPTYLINE HYDROCHLORIDE
Application Number
74835
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1997-06-30
Regulatory Status
Discontinued
Drug Name
NYLIA 1/35
Product Number
1
Dosage Form
-
Strength
0.035MG;1MG
Approval Date
2016-10-21
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
207056
Product Number
1
Dosage Form
-
Strength
0.035MG;1MG
Approval Date
2016-10-21
Regulatory Status
RX
Drug Name
NYLIA 7/7/7
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date
2016-10-21
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
207054
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date
2016-10-21
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2025-03-21
Active Ingredient
NYSTATIN
Application Number
219527
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2025-03-21
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
202050
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2012-04-23
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
202050
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2012-04-23
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
202050
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2012-04-23
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
202050
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2012-04-23
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
202050
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2012-04-23
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
202050
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2012-04-23
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2014-05-15
Active Ingredient
OLANZAPINE
Application Number
203708
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2014-05-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2014-05-15
Active Ingredient
OLANZAPINE
Application Number
203708
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2014-05-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2014-05-15
Active Ingredient
OLANZAPINE
Application Number
203708
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2014-05-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2014-05-15
Active Ingredient
OLANZAPINE
Application Number
203708
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2014-05-15
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
204798
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
204798
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
204798
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2017-04-24
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
205391
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2017-04-24
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
205391
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2017-04-24
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
205391
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OMEPRAZOLE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-08-19
Active Ingredient
OMEPRAZOLE
Application Number
203270
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-08-19
Regulatory Status
RX
Drug Name
OMEPRAZOLE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2015-08-19
Active Ingredient
OMEPRAZOLE
Application Number
203270
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2015-08-19
Regulatory Status
RX
Drug Name
OMEPRAZOLE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2015-08-19
Active Ingredient
OMEPRAZOLE
Application Number
203270
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2015-08-19
Regulatory Status
RX
Drug Name
OMEPRAZOLE AND SODIUM BICARBONATE
Product Number
1
Dosage Form
-
Strength
20MG;1.1GM
Approval Date
2016-11-07
Active Ingredient
OMEPRAZOLE; SODIUM BICARBONATE
Application Number
204923
Product Number
1
Dosage Form
-
Strength
20MG;1.1GM
Approval Date
2016-11-07
Regulatory Status
OTC
Drug Name
OMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2018-06-06
Active Ingredient
OMEPRAZOLE MAGNESIUM
Application Number
206877
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2018-06-06
Regulatory Status
OTC
Drug Name
OMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2023-04-28
Active Ingredient
OMEPRAZOLE MAGNESIUM
Application Number
213201
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2023-04-28
Regulatory Status
Discontinued
Drug Name
ONDANSETRON
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2010-04-12
Active Ingredient
ONDANSETRON
Application Number
90469
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2010-04-12
Regulatory Status
RX
Drug Name
ONDANSETRON
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2010-04-12
Active Ingredient
ONDANSETRON
Application Number
90469
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2010-04-12
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2007-07-31
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
78539
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2007-07-31
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2007-07-31
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
78539
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2007-07-31
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE
Approval Date
2007-07-31
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
78539
Product Number
3
Dosage Form
-
Strength
EQ 24MG BASE
Approval Date
2007-07-31
Regulatory Status
Discontinued
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2007-11-28
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
78776
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2007-11-28
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2024-05-10
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
218131
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2024-05-10
Regulatory Status
RX
Drug Name
OSHIH
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2023-12-06
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
216558
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2023-12-06
Regulatory Status
Discontinued
Drug Name
OXCARBAZEPINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2025-04-30
Active Ingredient
OXCARBAZEPINE
Application Number
219241
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2025-04-30
Regulatory Status
Discontinued
Drug Name
OXCARBAZEPINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-04-30
Active Ingredient
OXCARBAZEPINE
Application Number
219241
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-04-30
Regulatory Status
Discontinued
Drug Name
OXCARBAZEPINE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2025-04-30
Active Ingredient
OXCARBAZEPINE
Application Number
219241
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2025-04-30
Regulatory Status
Discontinued
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-09-28
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
202038
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-09-28
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-09-28
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
202038
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-09-28
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2025-03-31
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
217923
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2025-03-31
Regulatory Status
RX
Drug Name
PARICALCITOL
Product Number
1
Dosage Form
-
Strength
1MCG
Approval Date
2016-01-14
Active Ingredient
PARICALCITOL
Application Number
207672
Product Number
1
Dosage Form
-
Strength
1MCG
Approval Date
2016-01-14
Regulatory Status
RX
Drug Name
PARICALCITOL
Product Number
2
Dosage Form
-
Strength
2MCG
Approval Date
2016-01-14
Active Ingredient
PARICALCITOL
Application Number
207672
Product Number
2
Dosage Form
-
Strength
2MCG
Approval Date
2016-01-14
Regulatory Status
RX
Drug Name
PARICALCITOL
Product Number
3
Dosage Form
-
Strength
4MCG
Approval Date
2016-01-14
Active Ingredient
PARICALCITOL
Application Number
207672
Product Number
3
Dosage Form
-
Strength
4MCG
Approval Date
2016-01-14
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-07-25
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78406
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-07-25
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2007-07-25
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78406
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2007-07-25
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2007-07-25
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78406
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2007-07-25
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2007-07-25
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78406
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2007-07-25
Regulatory Status
RX
Drug Name
PENICILLIN V POTASSIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2008-04-29
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
65435
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2008-04-29
Regulatory Status
RX
Drug Name
PENICILLIN V POTASSIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2008-04-29
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
65435
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2008-04-29
Regulatory Status
RX
Drug Name
PERINDOPRIL ERBUMINE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2009-11-10
Active Ingredient
PERINDOPRIL ERBUMINE
Application Number
79070
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
PERINDOPRIL ERBUMINE
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2009-11-10
Active Ingredient
PERINDOPRIL ERBUMINE
Application Number
79070
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
PERINDOPRIL ERBUMINE
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
2009-11-10
Active Ingredient
PERINDOPRIL ERBUMINE
Application Number
79070
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
PHENOXYBENZAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-05-08
Active Ingredient
PHENOXYBENZAMINE HYDROCHLORIDE
Application Number
215600
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-05-08
Regulatory Status
RX
Drug Name
PHENTERMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
37.5MG
Approval Date
2014-08-06
Active Ingredient
PHENTERMINE HYDROCHLORIDE
Application Number
203068
Product Number
1
Dosage Form
-
Strength
37.5MG
Approval Date
2014-08-06
Regulatory Status
RX
Drug Name
PIMAVANSERIN
Product Number
1
Dosage Form
-
Strength
34MG
Approval Date
-
Active Ingredient
PIMAVANSERIN
Application Number
214782
Product Number
1
Dosage Form
-
Strength
34MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2013-02-13
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
200268
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-02-13
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
200268
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2013-02-13
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
200268
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG;EQ 15MG BASE
Approval Date
2013-02-13
Active Ingredient
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Application Number
200823
Product Number
1
Dosage Form
-
Strength
500MG;EQ 15MG BASE
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG;EQ 15MG BASE
Approval Date
2013-02-13
Active Ingredient
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Application Number
200823
Product Number
2
Dosage Form
-
Strength
850MG;EQ 15MG BASE
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2025-08-11
Active Ingredient
PIRFENIDONE
Application Number
212596
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2025-08-11
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2025-08-11
Active Ingredient
PIRFENIDONE
Application Number
212596
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2025-08-11
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2026-04-20
Active Ingredient
PIRFENIDONE
Application Number
212597
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2026-04-20
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2016-12-20
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206015
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2016-12-20
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2016-12-20
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206015
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2016-12-20
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2016-12-20
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206015
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2016-12-20
Regulatory Status
RX
Drug Name
POLYETHYLENE GLYCOL 3350
Product Number
1
Dosage Form
-
Strength
17GM/SCOOPFUL
Approval Date
2018-04-09
Active Ingredient
POLYETHYLENE GLYCOL 3350
Application Number
209017
Product Number
1
Dosage Form
-
Strength
17GM/SCOOPFUL
Approval Date
2018-04-09
Regulatory Status
OTC
Drug Name
POLYETHYLENE GLYCOL 3350
Product Number
2
Dosage Form
-
Strength
17GM/PACKET
Approval Date
2024-04-23
Active Ingredient
POLYETHYLENE GLYCOL 3350
Application Number
209017
Product Number
2
Dosage Form
-
Strength
17GM/PACKET
Approval Date
2024-04-23
Regulatory Status
OTC
Drug Name
POSACONAZOLE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2024-07-18
Active Ingredient
POSACONAZOLE
Application Number
217119
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2024-07-18
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
8MEQ
Approval Date
2018-12-19
Active Ingredient
POTASSIUM CHLORIDE
Application Number
210921
Product Number
1
Dosage Form
-
Strength
8MEQ
Approval Date
2018-12-19
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
10MEQ
Approval Date
2018-12-19
Active Ingredient
POTASSIUM CHLORIDE
Application Number
210921
Product Number
2
Dosage Form
-
Strength
10MEQ
Approval Date
2018-12-19
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
10MEQ
Approval Date
2021-03-31
Active Ingredient
POTASSIUM CHLORIDE
Application Number
214728
Product Number
1
Dosage Form
-
Strength
10MEQ
Approval Date
2021-03-31
Regulatory Status
Discontinued
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
15MEQ
Approval Date
2021-03-31
Active Ingredient
POTASSIUM CHLORIDE
Application Number
214728
Product Number
2
Dosage Form
-
Strength
15MEQ
Approval Date
2021-03-31
Regulatory Status
Discontinued
Drug Name
POTASSIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
20MEQ
Approval Date
2021-03-31
Active Ingredient
POTASSIUM CHLORIDE
Application Number
214728
Product Number
3
Dosage Form
-
Strength
20MEQ
Approval Date
2021-03-31
Regulatory Status
Discontinued
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MEQ/15ML
Approval Date
2025-11-20
Active Ingredient
POTASSIUM CHLORIDE
Application Number
216536
Product Number
1
Dosage Form
-
Strength
20MEQ/15ML
Approval Date
2025-11-20
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
40MEQ/15ML
Approval Date
2025-11-20
Active Ingredient
POTASSIUM CHLORIDE
Application Number
216536
Product Number
2
Dosage Form
-
Strength
40MEQ/15ML
Approval Date
2025-11-20
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2012-10-26
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202633
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2012-10-26
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2012-10-26
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202633
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2012-10-26
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2012-10-26
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202633
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2012-10-26
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
0.75MG
Approval Date
2012-10-26
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202633
Product Number
4
Dosage Form
-
Strength
0.75MG
Approval Date
2012-10-26
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
1MG
Approval Date
2012-10-26
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202633
Product Number
5
Dosage Form
-
Strength
1MG
Approval Date
2012-10-26
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
1.5MG
Approval Date
2012-10-26
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202633
Product Number
6
Dosage Form
-
Strength
1.5MG
Approval Date
2012-10-26
Regulatory Status
RX
Drug Name
PRASUGREL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-10-16
Active Ingredient
PRASUGREL HYDROCHLORIDE
Application Number
205888
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-10-16
Regulatory Status
RX
Drug Name
PRASUGREL
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-10-16
Active Ingredient
PRASUGREL HYDROCHLORIDE
Application Number
205888
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-10-16
Regulatory Status
RX
Drug Name
PRAVASTATIN SODIUM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-02-02
Active Ingredient
PRAVASTATIN SODIUM
Application Number
203367
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-02-02
Regulatory Status
RX
Drug Name
PRAVASTATIN SODIUM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-02-02
Active Ingredient
PRAVASTATIN SODIUM
Application Number
203367
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-02-02
Regulatory Status
RX
Drug Name
PRAVASTATIN SODIUM
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-02-02
Active Ingredient
PRAVASTATIN SODIUM
Application Number
203367
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-02-02
Regulatory Status
RX
Drug Name
PRAVASTATIN SODIUM
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2017-02-02
Active Ingredient
PRAVASTATIN SODIUM
Application Number
203367
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2017-02-02
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-03-31
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
213052
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-03-31
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-03-31
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
213052
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-03-31
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-03-31
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
213052
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-03-31
Regulatory Status
RX
Drug Name
PREDNISOLONE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-03-17
Active Ingredient
PREDNISOLONE
Application Number
215673
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-03-17
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2021-11-16
Active Ingredient
PREDNISONE
Application Number
215671
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2021-11-16
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2022-03-28
Active Ingredient
PREDNISONE
Application Number
215672
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2022-03-28
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2022-03-28
Active Ingredient
PREDNISONE
Application Number
215672
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2022-03-28
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2022-03-28
Active Ingredient
PREDNISONE
Application Number
215672
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2022-03-28
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2022-03-28
Active Ingredient
PREDNISONE
Application Number
215672
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2022-03-28
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2022-03-28
Active Ingredient
PREDNISONE
Application Number
215672
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2022-03-28
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2023-03-29
Active Ingredient
PREGABALIN
Application Number
205321
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2025-09-08
Active Ingredient
PROCHLORPERAZINE MALEATE
Application Number
218734
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2025-09-08
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2025-09-08
Active Ingredient
PROCHLORPERAZINE MALEATE
Application Number
218734
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2025-09-08
Regulatory Status
RX
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2016-05-11
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
202445
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2016-05-11
Regulatory Status
RX
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
225MG
Approval Date
2016-05-11
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
202445
Product Number
2
Dosage Form
-
Strength
225MG
Approval Date
2016-05-11
Regulatory Status
RX
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2016-05-11
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
202445
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2016-05-11
Regulatory Status
RX
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
225MG
Approval Date
2023-02-21
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
213096
Product Number
1
Dosage Form
-
Strength
225MG
Approval Date
2023-02-21
Regulatory Status
RX
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
325MG
Approval Date
2023-02-21
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
213096
Product Number
2
Dosage Form
-
Strength
325MG
Approval Date
2023-02-21
Regulatory Status
RX
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
425MG
Approval Date
2023-02-21
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
213096
Product Number
3
Dosage Form
-
Strength
425MG
Approval Date
2023-02-21
Regulatory Status
RX
Drug Name
PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2017-06-09
Active Ingredient
PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
209008
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2017-06-09
Regulatory Status
OTC
Drug Name
PSEUDOEPHEDRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
240MG
Approval Date
2025-12-29
Active Ingredient
PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
218854
Product Number
1
Dosage Form
-
Strength
240MG
Approval Date
2025-12-29
Regulatory Status
OTC
Drug Name
PYRIMETHAMINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-10-25
Active Ingredient
PYRIMETHAMINE
Application Number
216983
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-10-25
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
4
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
5
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
6
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
6
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
7
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
91388
Product Number
7
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
207655
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
207655
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
207655
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
207655
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
207655
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2013-04-29
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
202725
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2013-04-29
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2013-04-29
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
202725
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2013-04-29
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-04-29
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
202725
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-04-29
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-04-29
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
202725
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-04-29
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;EQ 10MG BASE
Approval Date
2007-08-24
Active Ingredient
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Application Number
78450
Product Number
1
Dosage Form
-
Strength
12.5MG;EQ 10MG BASE
Approval Date
2007-08-24
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;EQ 20MG BASE
Approval Date
2007-08-24
Active Ingredient
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Application Number
78450
Product Number
2
Dosage Form
-
Strength
12.5MG;EQ 20MG BASE
Approval Date
2007-08-24
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;EQ 20MG BASE
Approval Date
2007-08-24
Active Ingredient
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
Application Number
78450
Product Number
3
Dosage Form
-
Strength
25MG;EQ 20MG BASE
Approval Date
2007-08-24
Regulatory Status
RX
Drug Name
RALOXIFENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2015-08-28
Active Ingredient
RALOXIFENE HYDROCHLORIDE
Application Number
204310
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2015-08-28
Regulatory Status
RX
Drug Name
RAMELTEON
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
2023-07-10
Active Ingredient
RAMELTEON
Application Number
215972
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
2023-07-10
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2011-06-08
Active Ingredient
RAMIPRIL
Application Number
91604
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2011-06-08
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2011-06-08
Active Ingredient
RAMIPRIL
Application Number
91604
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2011-06-08
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2011-06-08
Active Ingredient
RAMIPRIL
Application Number
91604
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2011-06-08
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2011-06-08
Active Ingredient
RAMIPRIL
Application Number
91604
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2011-06-08
Regulatory Status
RX
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE/ML
Approval Date
2010-07-28
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
90623
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE/ML
Approval Date
2010-07-28
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-11-13
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
207578
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-11-13
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
207579
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-11-13
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-07-16
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
211058
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-07-16
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-07-16
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
211058
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-07-16
Regulatory Status
Discontinued
Drug Name
RANOLAZINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-12-23
Active Ingredient
RANOLAZINE
Application Number
209081
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-12-23
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2022-12-23
Active Ingredient
RANOLAZINE
Application Number
209081
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2022-12-23
Regulatory Status
RX
Drug Name
REPAGLINIDE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2014-01-22
Active Ingredient
REPAGLINIDE
Application Number
203820
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2014-01-22
Regulatory Status
RX
Drug Name
REPAGLINIDE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2014-01-22
Active Ingredient
REPAGLINIDE
Application Number
203820
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2014-01-22
Regulatory Status
RX
Drug Name
REPAGLINIDE
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2014-01-22
Active Ingredient
REPAGLINIDE
Application Number
203820
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2014-01-22
Regulatory Status
RX
Drug Name
RHUZDAH
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2022-10-11
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
207585
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2022-10-11
Regulatory Status
Discontinued
Drug Name
RIBAVIRIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2009-09-17
Active Ingredient
RIBAVIRIN
Application Number
79111
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2009-09-17
Regulatory Status
RX
Drug Name
RIBAVIRIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2009-09-17
Active Ingredient
RIBAVIRIN
Application Number
79117
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2009-09-17
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-11-30
Active Ingredient
RISEDRONATE SODIUM
Application Number
200296
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-11-30
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2015-11-30
Active Ingredient
RISEDRONATE SODIUM
Application Number
200296
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2015-11-30
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
3
Dosage Form
-
Strength
35MG
Approval Date
2015-11-30
Active Ingredient
RISEDRONATE SODIUM
Application Number
200296
Product Number
3
Dosage Form
-
Strength
35MG
Approval Date
2015-11-30
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2016-10-21
Active Ingredient
RISEDRONATE SODIUM
Application Number
206768
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2016-10-21
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-09-04
Active Ingredient
RISPERIDONE
Application Number
78452
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2009-09-04
Regulatory Status
RX
Drug Name
RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2018-09-17
Active Ingredient
RITONAVIR
Application Number
206614
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2018-09-17
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-04-10
Active Ingredient
RIVAROXABAN
Application Number
208544
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-04-10
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-05-15
Active Ingredient
RIVAROXABAN
Application Number
208544
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-05-15
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2025-05-15
Active Ingredient
RIVAROXABAN
Application Number
208544
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2025-05-15
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2025-05-15
Active Ingredient
RIVAROXABAN
Application Number
208544
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2025-05-15
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2016-03-25
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
204572
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2016-03-25
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2016-03-25
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
204572
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2016-03-25
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2016-03-25
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
204572
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2016-03-25
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2016-03-25
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
204572
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2016-03-25
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-12-31
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
202490
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-12-31
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-12-31
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
202490
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-12-31
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2013-07-01
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
203062
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2013-07-01
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2013-07-01
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
203062
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2013-07-01
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
1
Dosage Form
-
Strength
500MCG
Approval Date
2023-04-17
Active Ingredient
ROFLUMILAST
Application Number
213298
Product Number
1
Dosage Form
-
Strength
500MCG
Approval Date
2023-04-17
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
2
Dosage Form
-
Strength
250MCG
Approval Date
2025-01-31
Active Ingredient
ROFLUMILAST
Application Number
213298
Product Number
2
Dosage Form
-
Strength
250MCG
Approval Date
2025-01-31
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79170
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2016-07-19
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79170
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-07-19
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79170
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-07-19
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-07-19
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
79170
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-07-19
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-10-26
Active Ingredient
RUFINAMIDE
Application Number
216549
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-10-26
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2023-06-16
Active Ingredient
RUFINAMIDE
Application Number
217230
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2023-06-16
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2023-06-16
Active Ingredient
RUFINAMIDE
Application Number
217230
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2023-06-16
Regulatory Status
RX
Drug Name
SAFINAMIDE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-06-14
Active Ingredient
SAFINAMIDE MESYLATE
Application Number
215902
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-06-14
Regulatory Status
Discontinued
Drug Name
SAFINAMIDE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-06-14
Active Ingredient
SAFINAMIDE MESYLATE
Application Number
215902
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-06-14
Regulatory Status
Discontinued
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-06-09
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
216797
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-06-09
Regulatory Status
RX
Drug Name
SAXAGLIPTIN
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2023-07-31
Active Ingredient
SAXAGLIPTIN HYDROCHLORIDE
Application Number
205972
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-07-31
Active Ingredient
SAXAGLIPTIN HYDROCHLORIDE
Application Number
205972
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77206
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77206
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77206
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
2008-10-31
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
78861
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2017-07-17
Active Ingredient
SEVELAMER CARBONATE
Application Number
207179
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2017-07-17
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
1
Dosage Form
-
Strength
800MG/PACKET
Approval Date
2017-06-13
Active Ingredient
SEVELAMER CARBONATE
Application Number
207624
Product Number
1
Dosage Form
-
Strength
800MG/PACKET
Approval Date
2017-06-13
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
2
Dosage Form
-
Strength
2.4GM/PACKET
Approval Date
2017-06-13
Active Ingredient
SEVELAMER CARBONATE
Application Number
207624
Product Number
2
Dosage Form
-
Strength
2.4GM/PACKET
Approval Date
2017-06-13
Regulatory Status
RX
Drug Name
SEVELAMER HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2023-07-11
Active Ingredient
SEVELAMER HYDROCHLORIDE
Application Number
212599
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2023-07-11
Regulatory Status
RX
Drug Name
SEVELAMER HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-07-11
Active Ingredient
SEVELAMER HYDROCHLORIDE
Application Number
212599
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-07-11
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-06-11
Active Ingredient
SILDENAFIL CITRATE
Application Number
203962
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-06-11
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2018-06-11
Active Ingredient
SILDENAFIL CITRATE
Application Number
203962
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2018-06-11
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-06-11
Active Ingredient
SILDENAFIL CITRATE
Application Number
203962
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-06-11
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-11-18
Active Ingredient
SILDENAFIL CITRATE
Application Number
203963
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-11-18
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2022-12-23
Active Ingredient
SILDENAFIL CITRATE
Application Number
214773
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2022-12-23
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-10
Active Ingredient
SILODOSIN
Application Number
210626
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-10
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-10
Active Ingredient
SILODOSIN
Application Number
210626
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-10
Regulatory Status
RX
Drug Name
SIMLIYA
Product Number
1
Dosage Form
-
Strength
0.15MG,N/A;0.02MG,0.01MG
Approval Date
2017-03-22
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
206853
Product Number
1
Dosage Form
-
Strength
0.15MG,N/A;0.02MG,0.01MG
Approval Date
2017-03-22
Regulatory Status
RX
Drug Name
SIMPESSE
Product Number
1
Dosage Form
-
Strength
0.03MG,0.01MG;0.15MG,N/A
Approval Date
2017-04-07
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
206851
Product Number
1
Dosage Form
-
Strength
0.03MG,0.01MG;0.15MG,N/A
Approval Date
2017-04-07
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2006-12-20
Active Ingredient
SIMVASTATIN
Application Number
77691
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2006-12-20
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2006-12-20
Active Ingredient
SIMVASTATIN
Application Number
77691
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2006-12-20
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2006-12-20
Active Ingredient
SIMVASTATIN
Application Number
77691
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2006-12-20
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2006-12-20
Active Ingredient
SIMVASTATIN
Application Number
77691
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2006-12-20
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
5
Dosage Form
-
Strength
80MG
Approval Date
2006-12-20
Active Ingredient
SIMVASTATIN
Application Number
77691
Product Number
5
Dosage Form
-
Strength
80MG
Approval Date
2006-12-20
Regulatory Status
RX
Drug Name
SIPONIMOD
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2026-03-06
Active Ingredient
SIPONIMOD
Application Number
218459
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2026-03-06
Regulatory Status
Discontinued
Drug Name
SIPONIMOD
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-03-06
Active Ingredient
SIPONIMOD
Application Number
218459
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-03-06
Regulatory Status
Discontinued
Drug Name
SIPONIMOD
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2026-03-06
Active Ingredient
SIPONIMOD
Application Number
218459
Product Number
3
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2026-03-06
Regulatory Status
Discontinued
Drug Name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Application Number
214859
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1000MG
Approval Date
-
Active Ingredient
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Application Number
214859
Product Number
3
Dosage Form
-
Strength
1000MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SOLIFENACIN SUCCINATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-12-27
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
206817
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-12-27
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-12-27
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
206817
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-12-27
Regulatory Status
RX
Drug Name
SOLRIAMFETOL
Product Number
2
Dosage Form
-
Strength
75MG
Approval Date
-
Active Ingredient
SOLRIAMFETOL
Application Number
218725
Product Number
2
Dosage Form
-
Strength
75MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SOLRIAMFETOL
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
SOLRIAMFETOL
Application Number
218725
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SPIRONOLACTONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2014-03-06
Active Ingredient
SPIRONOLACTONE
Application Number
202187
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2014-03-06
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2014-03-06
Active Ingredient
SPIRONOLACTONE
Application Number
202187
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2014-03-06
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2014-03-06
Active Ingredient
SPIRONOLACTONE
Application Number
202187
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2014-03-06
Regulatory Status
RX
Drug Name
STAVUDINE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2008-12-29
Active Ingredient
STAVUDINE
Application Number
77672
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2008-12-29
Regulatory Status
Discontinued
Drug Name
STAVUDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2008-12-29
Active Ingredient
STAVUDINE
Application Number
77672
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2008-12-29
Regulatory Status
Discontinued
Drug Name
STAVUDINE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2008-12-29
Active Ingredient
STAVUDINE
Application Number
77672
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2008-12-29
Regulatory Status
Discontinued
Drug Name
STAVUDINE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2008-12-29
Active Ingredient
STAVUDINE
Application Number
77672
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2008-12-29
Regulatory Status
Discontinued
Drug Name
STAVUDINE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2008-12-29
Active Ingredient
STAVUDINE
Application Number
77774
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2008-12-29
Regulatory Status
Discontinued
Drug Name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Product Number
1
Dosage Form
-
Strength
400MG;80MG
Approval Date
2010-02-16
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
90624
Product Number
1
Dosage Form
-
Strength
400MG;80MG
Approval Date
2010-02-16
Regulatory Status
RX
Drug Name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Product Number
2
Dosage Form
-
Strength
800MG;160MG
Approval Date
2010-02-16
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
90624
Product Number
2
Dosage Form
-
Strength
800MG;160MG
Approval Date
2010-02-16
Regulatory Status
RX
Drug Name
SULFAMETHOXAZOLE AND TRIMETHOPRIM
Product Number
1
Dosage Form
-
Strength
200MG/5ML;40MG/5ML
Approval Date
2010-06-08
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
91348
Product Number
1
Dosage Form
-
Strength
200MG/5ML;40MG/5ML
Approval Date
2010-06-08
Regulatory Status
RX
Drug Name
SUMATRIPTAN AND NAPROXEN SODIUM
Product Number
1
Dosage Form
-
Strength
500MG;EQ 85MG BASE
Approval Date
2018-02-15
Active Ingredient
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Application Number
207457
Product Number
1
Dosage Form
-
Strength
500MG;EQ 85MG BASE
Approval Date
2018-02-15
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
78327
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
78327
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
78327
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
206285
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
206285
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
206285
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
206285
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-02-05
Active Ingredient
TADALAFIL
Application Number
206286
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-02-05
Regulatory Status
RX
Drug Name
TAMSULOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG
Approval Date
2013-04-30
Active Ingredient
TAMSULOSIN HYDROCHLORIDE
Application Number
202433
Product Number
1
Dosage Form
-
Strength
0.4MG
Approval Date
2013-04-30
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2015-09-03
Active Ingredient
TELMISARTAN
Application Number
206511
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2015-09-03
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2015-09-03
Active Ingredient
TELMISARTAN
Application Number
206511
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2015-09-03
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2015-09-03
Active Ingredient
TELMISARTAN
Application Number
206511
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2015-09-03
Regulatory Status
RX
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2016-12-15
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
208727
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2016-12-15
Regulatory Status
RX
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2016-12-15
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
208727
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2016-12-15
Regulatory Status
RX
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2016-12-15
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
208727
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2016-12-15
Regulatory Status
RX
Drug Name
TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2018-01-26
Active Ingredient
TENOFOVIR DISOPROXIL FUMARATE
Application Number
90647
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2018-01-26
Regulatory Status
RX
Drug Name
TENOFOVIR DISOPROXIL FUMARATE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2018-01-26
Active Ingredient
TENOFOVIR DISOPROXIL FUMARATE
Application Number
90647
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2018-01-26
Regulatory Status
RX
Drug Name
TENOFOVIR DISOPROXIL FUMARATE
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2018-01-26
Active Ingredient
TENOFOVIR DISOPROXIL FUMARATE
Application Number
90647
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2018-01-26
Regulatory Status
RX
Drug Name
TENOFOVIR DISOPROXIL FUMARATE
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2018-01-26
Active Ingredient
TENOFOVIR DISOPROXIL FUMARATE
Application Number
90647
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2018-01-26
Regulatory Status
RX
Drug Name
TERBINAFINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2007-07-02
Active Ingredient
TERBINAFINE HYDROCHLORIDE
Application Number
78297
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2007-07-02
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2018-10-26
Active Ingredient
TERIFLUNOMIDE
Application Number
209638
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2018-10-26
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2018-10-26
Active Ingredient
TERIFLUNOMIDE
Application Number
209638
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2018-10-26
Regulatory Status
RX
Drug Name
TIZANIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2020-03-24
Active Ingredient
TIZANIDINE HYDROCHLORIDE
Application Number
213544
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2020-03-24
Regulatory Status
RX
Drug Name
TIZANIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2020-03-24
Active Ingredient
TIZANIDINE HYDROCHLORIDE
Application Number
213544
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2020-03-24
Regulatory Status
RX
Drug Name
TIZANIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2020-03-24
Active Ingredient
TIZANIDINE HYDROCHLORIDE
Application Number
213544
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2020-03-24
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2026-06-03
Active Ingredient
TOFACITINIB CITRATE
Application Number
215356
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2026-06-03
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-06-03
Active Ingredient
TOFACITINIB CITRATE
Application Number
215356
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-06-03
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 11MG BASE
Approval Date
2024-06-03
Active Ingredient
TOFACITINIB CITRATE
Application Number
218462
Product Number
1
Dosage Form
-
Strength
EQ 11MG BASE
Approval Date
2024-06-03
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
78462
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
78462
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
78462
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
78462
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-03-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2023-09-27
Active Ingredient
TOPIRAMATE
Application Number
215449
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2023-09-27
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-09-27
Active Ingredient
TOPIRAMATE
Application Number
215449
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-09-27
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-10-17
Active Ingredient
TORSEMIDE
Application Number
78249
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-10-17
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-10-17
Active Ingredient
TORSEMIDE
Application Number
78249
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-10-17
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2007-10-17
Active Ingredient
TORSEMIDE
Application Number
78249
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2007-10-17
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2007-10-17
Active Ingredient
TORSEMIDE
Application Number
78249
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2007-10-17
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2014-03-31
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
203494
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2014-03-31
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2015-10-20
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
204421
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2015-10-20
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2015-10-20
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
204421
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2015-10-20
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2015-10-20
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
204421
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2015-10-20
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
2017-03-22
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Application Number
207152
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
2017-03-22
Regulatory Status
RX
Drug Name
TRANDOLAPRIL
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2007-06-12
Active Ingredient
TRANDOLAPRIL
Application Number
78438
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2007-06-12
Regulatory Status
RX
Drug Name
TRANDOLAPRIL
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2007-06-12
Active Ingredient
TRANDOLAPRIL
Application Number
78438
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2007-06-12
Regulatory Status
RX
Drug Name
TRANDOLAPRIL
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2007-06-12
Active Ingredient
TRANDOLAPRIL
Application Number
78438
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2007-06-12
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2020-02-05
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
204852
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2020-02-05
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2020-02-05
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
204852
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2020-02-05
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2020-02-05
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
204852
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2020-02-05
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2020-02-05
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
204852
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2020-02-05
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2025-02-27
Active Ingredient
TRETINOIN
Application Number
218245
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2025-02-27
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2025-01-13
Active Ingredient
TRETINOIN
Application Number
218246
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
TRI-LO-MILI
Product Number
1
Dosage Form
-
Strength
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date
2016-11-04
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
205762
Product Number
1
Dosage Form
-
Strength
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date
2016-11-04
Regulatory Status
RX
Drug Name
TRI-MILI
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date
2016-07-06
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
205441
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date
2016-07-06
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2020-03-18
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
211315
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2020-03-18
Regulatory Status
Discontinued
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2020-03-18
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
211315
Product Number
2
Dosage Form
-
Strength
0.5%
Approval Date
2020-03-18
Regulatory Status
Discontinued
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.055MG/SPRAY
Approval Date
2026-08-11
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
220110
Product Number
1
Dosage Form
-
Strength
0.055MG/SPRAY
Approval Date
2026-08-11
Regulatory Status
OTC
Drug Name
UBROGEPANT
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
UBROGEPANT
Application Number
219088
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
UBROGEPANT
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
UBROGEPANT
Application Number
219088
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
UPADACITINIB
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
-
Active Ingredient
UPADACITINIB
Application Number
218866
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
UPADACITINIB
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
-
Active Ingredient
UPADACITINIB
Application Number
218866
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
URSODIOL
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2022-11-28
Active Ingredient
URSODIOL
Application Number
214849
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2022-11-28
Regulatory Status
RX
Drug Name
VALACYCLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2010-05-24
Active Ingredient
VALACYCLOVIR HYDROCHLORIDE
Application Number
90682
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2010-05-24
Regulatory Status
RX
Drug Name
VALACYCLOVIR HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE
Approval Date
2010-05-24
Active Ingredient
VALACYCLOVIR HYDROCHLORIDE
Application Number
90682
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE
Approval Date
2010-05-24
Regulatory Status
RX
Drug Name
VALGANCICLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 450MG BASE
Approval Date
2016-03-31
Active Ingredient
VALGANCICLOVIR HYDROCHLORIDE
Application Number
204750
Product Number
1
Dosage Form
-
Strength
EQ 450MG BASE
Approval Date
2016-03-31
Regulatory Status
RX
Drug Name
VALGANCICLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2022-11-17
Active Ingredient
VALGANCICLOVIR HYDROCHLORIDE
Application Number
215124
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2022-11-17
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202223
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202223
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202223
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202223
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
202519
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
202519
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
202519
Product Number
3
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
25MG;160MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
202519
Product Number
4
Dosage Form
-
Strength
25MG;160MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
202519
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
2026-08-07
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
218130
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
2026-08-07
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2026-08-07
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
218130
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2026-08-07
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-05-02
Active Ingredient
VARENICLINE TARTRATE
Application Number
214595
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-05-02
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-05-02
Active Ingredient
VARENICLINE TARTRATE
Application Number
214595
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-05-02
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2010-04-07
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90555
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2010-04-07
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2010-04-07
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90555
Product Number
2
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2010-04-07
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2010-04-07
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90555
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2010-04-07
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2010-04-07
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90555
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2010-04-07
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2010-04-07
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90555
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2010-04-07
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2011-04-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
200834
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2011-04-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2011-04-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
200834
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2011-04-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2011-04-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
200834
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2011-04-14
Regulatory Status
RX
Drug Name
VIGABATRIN
Product Number
1
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2021-09-29
Active Ingredient
VIGABATRIN
Application Number
213899
Product Number
1
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2021-09-29
Regulatory Status
RX
Drug Name
VIGABATRIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-05-10
Active Ingredient
VIGABATRIN
Application Number
215601
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-05-10
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2016-01-22
Active Ingredient
VORICONAZOLE
Application Number
206837
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2016-01-22
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2016-01-22
Active Ingredient
VORICONAZOLE
Application Number
206837
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2016-01-22
Regulatory Status
RX
Drug Name
ZAFIRLUKAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-11-27
Active Ingredient
ZAFIRLUKAST
Application Number
213163
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-11-27
Regulatory Status
RX
Drug Name
ZAFIRLUKAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-11-27
Active Ingredient
ZAFIRLUKAST
Application Number
213163
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-11-27
Regulatory Status
RX
Drug Name
ZALEPLON
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-06-06
Active Ingredient
ZALEPLON
Application Number
78829
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2008-06-06
Regulatory Status
RX
Drug Name
ZALEPLON
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-06-06
Active Ingredient
ZALEPLON
Application Number
78829
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2008-06-06
Regulatory Status
RX
Drug Name
ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2009-07-23
Active Ingredient
ZIDOVUDINE
Application Number
22294
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2009-07-23
Regulatory Status
Discontinued
Drug Name
ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2005-09-19
Active Ingredient
ZIDOVUDINE
Application Number
77267
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2005-09-19
Regulatory Status
RX
Drug Name
ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
2005-09-19
Active Ingredient
ZIDOVUDINE
Application Number
77268
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
2005-09-19
Regulatory Status
RX
Drug Name
ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2006-03-27
Active Ingredient
ZIDOVUDINE
Application Number
78128
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2006-03-27
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-12-27
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204117
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-12-27
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-12-27
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204117
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-12-27
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2016-12-27
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204117
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2016-12-27
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2016-12-27
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204117
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2016-12-27
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2016-05-11
Active Ingredient
ZOLMITRIPTAN
Application Number
207021
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2016-05-11
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2016-05-11
Active Ingredient
ZOLMITRIPTAN
Application Number
207021
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2016-05-11
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-05-04
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
78413
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-05-04
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-05-04
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
78413
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-05-04
Regulatory Status
RX
Drug Name
ZONISAMIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-12-22
Active Ingredient
ZONISAMIDE
Application Number
77645
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-12-22
Regulatory Status
RX
Drug Name
ZONISAMIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2006-09-29
Active Ingredient
ZONISAMIDE
Application Number
77645
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2006-09-29
Regulatory Status
RX
Drug Name
ZONISAMIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2006-09-29
Active Ingredient
ZONISAMIDE
Application Number
77645
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2006-09-29
Regulatory Status
RX
Drug Name
ZUMANDIMINE
Product Number
1
Dosage Form
-
Strength
3MG;0.03MG
Approval Date
2018-03-26
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
209407
Product Number
1
Dosage Form
-
Strength
3MG;0.03MG
Approval Date
2018-03-26
Regulatory Status
RX
Drug Status Breakdown
1128 total- Unclassified
- RX
- Discontinued
- OTC
Official Source
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Drug Name
ABACAVIR SULFATE
Application Number
22293
Product Number
1
Active Ingredient
ABACAVIR SULFATE
Dosage Form
-
Strength
60MG
FDA Approved Drug Data
Approved drug product information
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