Torrent Pharmaceuticals Limited
FDA Approved Drugs
Torrent Pharmaceuticals 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 326
- Latest Approval Date May 20, 2026
- Data Source FDA
- First Approval Date Nov 30, 2000
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Torrent Pharmaceuticals Limited
Off. Ashram Road, Ahmedabad - 380 009, Gujarat
India
www.torrentpharma.com/ View on MapFDA Approved Drug Records ( 326 records )
Drug Name
ACETAZOLAMIDE
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2024-01-26
Active Ingredient
ACETAZOLAMIDE
Application Number
213706
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2024-01-26
Regulatory Status
Discontinued
Drug Name
ACETAZOLAMIDE
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2024-01-26
Active Ingredient
ACETAZOLAMIDE
Application Number
213706
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2024-01-26
Regulatory Status
Discontinued
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2019-01-11
Active Ingredient
ACYCLOVIR
Application Number
209971
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2019-01-11
Regulatory Status
RX
Drug Name
ALFUZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-07-18
Active Ingredient
ALFUZOSIN HYDROCHLORIDE
Application Number
79054
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-07-18
Regulatory Status
Discontinued
Drug Name
ALOGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE;500MG
Approval Date
-
Active Ingredient
ALOGLIPTIN; METFORMIN HYDROCHLORIDE
Application Number
210160
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE;500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ALOGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE;1GM
Approval Date
-
Active Ingredient
ALOGLIPTIN; METFORMIN HYDROCHLORIDE
Application Number
210160
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE;1GM
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2016-11-25
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
202933
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2016-11-25
Regulatory Status
Discontinued
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2016-11-25
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
202933
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2016-11-25
Regulatory Status
Discontinued
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2016-11-25
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
202933
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2016-11-25
Regulatory Status
Discontinued
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2016-11-25
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
202933
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2016-11-25
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2008-09-22
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78573
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2008-09-22
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2008-09-22
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78573
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2008-09-22
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-09-22
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78573
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-09-22
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202377
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-03-30
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202377
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-03-30
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202377
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-03-30
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202377
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-03-30
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;160MG
Approval Date
2015-06-03
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201593
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;160MG
Approval Date
2015-06-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;25MG;160MG
Approval Date
2015-06-03
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201593
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;25MG;160MG
Approval Date
2015-06-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;160MG
Approval Date
2015-06-03
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201593
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;160MG
Approval Date
2015-06-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;25MG;160MG
Approval Date
2015-06-03
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201593
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;25MG;160MG
Approval Date
2015-06-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;320MG
Approval Date
2015-06-03
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201593
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;320MG
Approval Date
2015-06-03
Regulatory Status
Discontinued
Drug Name
ANAGRELIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2017-06-30
Active Ingredient
ANAGRELIDE HYDROCHLORIDE
Application Number
209151
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2017-06-30
Regulatory Status
RX
Drug Name
ANAGRELIDE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2017-06-30
Active Ingredient
ANAGRELIDE HYDROCHLORIDE
Application Number
209151
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2017-06-30
Regulatory Status
RX
Drug Name
APIXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2024-12-17
Active Ingredient
APIXABAN
Application Number
210156
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2024-12-17
Regulatory Status
Discontinued
Drug Name
APIXABAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2024-12-17
Active Ingredient
APIXABAN
Application Number
210156
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2024-12-17
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-06-20
Active Ingredient
APREMILAST
Application Number
211834
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-06-20
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2025-06-20
Active Ingredient
APREMILAST
Application Number
211834
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2025-06-20
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2025-06-20
Active Ingredient
APREMILAST
Application Number
211834
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2025-06-20
Regulatory Status
Discontinued
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
201519
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
201519
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
201519
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
201519
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
201519
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
201519
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2014-10-31
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
203969
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2014-10-31
Regulatory Status
Discontinued
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2014-10-31
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
203969
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2014-10-31
Regulatory Status
Discontinued
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2014-10-31
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
203969
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2014-10-31
Regulatory Status
Discontinued
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2001-07-05
Active Ingredient
CARBAMAZEPINE
Application Number
75712
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2001-07-05
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-12-07
Active Ingredient
CARBAMAZEPINE
Application Number
77272
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2005-12-07
Regulatory Status
Discontinued
Drug Name
CARBAMAZEPINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2005-12-07
Active Ingredient
CARBAMAZEPINE
Application Number
77272
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2005-12-07
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2005-12-07
Active Ingredient
CARBAMAZEPINE
Application Number
77272
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2005-12-07
Regulatory Status
Discontinued
Drug Name
CARBAMAZEPINE
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2005-12-07
Active Ingredient
CARBAMAZEPINE
Application Number
77272
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2005-12-07
Regulatory Status
Discontinued
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-01-13
Active Ingredient
CARBAMAZEPINE
Application Number
212524
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-01-13
Active Ingredient
CARBAMAZEPINE
Application Number
212524
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2025-01-13
Active Ingredient
CARBAMAZEPINE
Application Number
212524
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2015-12-23
Active Ingredient
CELECOXIB
Application Number
207677
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2015-12-23
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-12-23
Active Ingredient
CELECOXIB
Application Number
207677
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-12-23
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2015-12-23
Active Ingredient
CELECOXIB
Application Number
207677
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2015-12-23
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2015-12-23
Active Ingredient
CELECOXIB
Application Number
207677
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2015-12-23
Regulatory Status
RX
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2010-04-15
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
79191
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2010-04-15
Regulatory Status
Discontinued
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2010-04-15
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
79191
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2010-04-15
Regulatory Status
Discontinued
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2010-04-15
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
79191
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2010-04-15
Regulatory Status
Discontinued
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2010-04-15
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
79191
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2010-04-15
Regulatory Status
Discontinued
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2023-12-14
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Application Number
217385
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2023-12-14
Regulatory Status
Discontinued
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-03-27
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
78216
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-03-27
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2007-03-27
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
78216
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2007-03-27
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2007-03-27
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
78216
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2007-03-27
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-12-30
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
211836
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-12-30
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-25
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
212926
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-25
Regulatory Status
Discontinued
Drug Name
CLOPIDOGREL BISULFATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2012-05-17
Active Ingredient
CLOPIDOGREL BISULFATE
Application Number
90844
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2012-05-17
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;EQ 5MG BASE
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Application Number
211537
Product Number
1
Dosage Form
-
Strength
10MG;EQ 5MG BASE
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2022-02-10
Active Ingredient
DAPSONE
Application Number
214722
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2022-02-10
Regulatory Status
RX
Drug Name
DARIFENACIN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2016-11-17
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
205209
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2016-11-17
Regulatory Status
RX
Drug Name
DARIFENACIN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2016-11-17
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
205209
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2016-11-17
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2024-11-05
Active Ingredient
DEFERASIROX
Application Number
209426
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2024-11-05
Regulatory Status
Discontinued
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2024-11-05
Active Ingredient
DEFERASIROX
Application Number
209426
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2024-11-05
Regulatory Status
Discontinued
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2024-11-05
Active Ingredient
DEFERASIROX
Application Number
209426
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2024-11-05
Regulatory Status
Discontinued
Drug Name
DICLOFENAC POTASSIUM
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2025-01-22
Active Ingredient
DICLOFENAC POTASSIUM
Application Number
215891
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2025-01-22
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2025-01-06
Active Ingredient
DIMETHYL FUMARATE
Application Number
210390
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2025-01-06
Regulatory Status
Discontinued
Drug Name
DIMETHYL FUMARATE
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2025-01-06
Active Ingredient
DIMETHYL FUMARATE
Application Number
210390
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2025-01-06
Regulatory Status
Discontinued
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-05-31
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
90686
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
90686
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-05-31
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-04-15
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
214356
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-04-15
Regulatory Status
Discontinued
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-04-15
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
214356
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-04-15
Regulatory Status
Discontinued
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90774
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-11
Regulatory Status
Discontinued
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90774
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-12-11
Regulatory Status
Discontinued
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90774
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-12-11
Regulatory Status
Discontinued
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
90939
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
90939
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
90939
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
2024-02-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211227
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-02-27
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2024-02-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211227
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2024-02-27
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2024-02-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211227
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2024-02-27
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2024-02-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211227
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2024-02-27
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-10-19
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
203636
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-10-19
Regulatory Status
Discontinued
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2015-10-19
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
203636
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2015-10-19
Regulatory Status
Discontinued
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE/PACKET
Approval Date
2025-03-05
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
212651
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE/PACKET
Approval Date
2025-03-05
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/PACKET
Approval Date
2025-03-05
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
212651
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/PACKET
Approval Date
2025-03-05
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE/PACKET
Approval Date
2025-03-05
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
212651
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE/PACKET
Approval Date
2025-03-05
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE/PACKET
Approval Date
2025-03-05
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
212651
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE/PACKET
Approval Date
2025-03-05
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/PACKET
Approval Date
2025-03-05
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
212652
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/PACKET
Approval Date
2025-03-05
Regulatory Status
RX
Drug Name
EZETIMIBE AND SIMVASTATIN
Product Number
1
Dosage Form
-
Strength
10MG;10MG
Approval Date
2025-01-27
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
209461
Product Number
1
Dosage Form
-
Strength
10MG;10MG
Approval Date
2025-01-27
Regulatory Status
Discontinued
Drug Name
EZETIMIBE AND SIMVASTATIN
Product Number
2
Dosage Form
-
Strength
10MG;20MG
Approval Date
2025-01-27
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
209461
Product Number
2
Dosage Form
-
Strength
10MG;20MG
Approval Date
2025-01-27
Regulatory Status
Discontinued
Drug Name
EZETIMIBE AND SIMVASTATIN
Product Number
3
Dosage Form
-
Strength
10MG;40MG
Approval Date
2025-01-27
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
209461
Product Number
3
Dosage Form
-
Strength
10MG;40MG
Approval Date
2025-01-27
Regulatory Status
Discontinued
Drug Name
EZETIMIBE AND SIMVASTATIN
Product Number
4
Dosage Form
-
Strength
10MG;80MG
Approval Date
2025-01-27
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
209461
Product Number
4
Dosage Form
-
Strength
10MG;80MG
Approval Date
2025-01-27
Regulatory Status
Discontinued
Drug Name
FEBUXOSTAT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2023-12-19
Active Ingredient
FEBUXOSTAT
Application Number
211837
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2023-12-19
Regulatory Status
Discontinued
Drug Name
FEBUXOSTAT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2023-12-19
Active Ingredient
FEBUXOSTAT
Application Number
211837
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2023-12-19
Regulatory Status
Discontinued
Drug Name
FELODIPINE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2011-11-28
Active Ingredient
FELODIPINE
Application Number
202170
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2011-11-28
Regulatory Status
RX
Drug Name
FELODIPINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2011-11-28
Active Ingredient
FELODIPINE
Application Number
202170
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2011-11-28
Regulatory Status
RX
Drug Name
FELODIPINE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2011-11-28
Active Ingredient
FELODIPINE
Application Number
202170
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2011-11-28
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2018-06-26
Active Ingredient
FENOFIBRATE
Application Number
210782
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2018-06-26
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2018-06-26
Active Ingredient
FENOFIBRATE
Application Number
210782
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2018-06-26
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2018-06-26
Active Ingredient
FENOFIBRATE
Application Number
210782
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2018-06-26
Regulatory Status
RX
Drug Name
FIDAXOMICIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2026-01-27
Active Ingredient
FIDAXOMICIN
Application Number
220374
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-10-21
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
206937
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-10-21
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-10-21
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
206937
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-10-21
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2024-01-22
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217094
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2024-01-22
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2024-01-22
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217094
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2024-01-22
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2024-01-22
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217094
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2024-01-22
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2024-01-22
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217094
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2024-01-22
Regulatory Status
Discontinued
Drug Name
FLUVOXAMINE MALEATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2014-10-31
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
203240
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2014-10-31
Regulatory Status
Discontinued
Drug Name
FLUVOXAMINE MALEATE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2014-10-31
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
203240
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2014-10-31
Regulatory Status
Discontinued
Drug Name
IBUPROFEN AND FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
26.6MG;800MG
Approval Date
2024-03-18
Active Ingredient
FAMOTIDINE; IBUPROFEN
Application Number
215925
Product Number
1
Dosage Form
-
Strength
26.6MG;800MG
Approval Date
2024-03-18
Regulatory Status
Discontinued
Drug Name
ISOSORBIDE MONONITRATE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2011-06-03
Active Ingredient
ISOSORBIDE MONONITRATE
Application Number
200270
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2011-06-03
Regulatory Status
RX
Drug Name
ISOSORBIDE MONONITRATE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2011-06-03
Active Ingredient
ISOSORBIDE MONONITRATE
Application Number
200495
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2011-06-03
Regulatory Status
RX
Drug Name
ISOSORBIDE MONONITRATE
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2011-06-03
Active Ingredient
ISOSORBIDE MONONITRATE
Application Number
200495
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2011-06-03
Regulatory Status
RX
Drug Name
ITRACONAZOLE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2018-08-24
Active Ingredient
ITRACONAZOLE
Application Number
209460
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2018-08-24
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-01-27
Active Ingredient
LAMOTRIGINE
Application Number
78947
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
78947
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
78947
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
78947
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-01-27
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2013-12-23
Active Ingredient
LAMOTRIGINE
Application Number
203370
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2013-12-23
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2013-12-23
Active Ingredient
LAMOTRIGINE
Application Number
203370
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2013-12-23
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2013-12-23
Active Ingredient
LAMOTRIGINE
Application Number
203370
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2013-12-23
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2013-12-23
Active Ingredient
LAMOTRIGINE
Application Number
203370
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2013-12-23
Regulatory Status
Discontinued
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-01-08
Active Ingredient
LAMOTRIGINE
Application Number
217100
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2026-01-08
Active Ingredient
LAMOTRIGINE
Application Number
217100
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2026-01-08
Active Ingredient
LAMOTRIGINE
Application Number
217100
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2026-01-08
Active Ingredient
LAMOTRIGINE
Application Number
217100
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-02-17
Active Ingredient
LENALIDOMIDE
Application Number
213405
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-02-17
Regulatory Status
Discontinued
Drug Name
LENALIDOMIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-02-17
Active Ingredient
LENALIDOMIDE
Application Number
213405
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-02-17
Regulatory Status
Discontinued
Drug Name
LENALIDOMIDE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2023-08-03
Active Ingredient
LENALIDOMIDE
Application Number
213405
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2023-08-03
Regulatory Status
Discontinued
Drug Name
LENALIDOMIDE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2025-11-04
Active Ingredient
LENALIDOMIDE
Application Number
213405
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2025-11-04
Regulatory Status
Discontinued
Drug Name
LENALIDOMIDE
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2026-02-10
Active Ingredient
LENALIDOMIDE
Application Number
213405
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2026-02-10
Regulatory Status
Discontinued
Drug Name
LENALIDOMIDE
Product Number
6
Dosage Form
-
Strength
5MG
Approval Date
2026-02-10
Active Ingredient
LENALIDOMIDE
Application Number
213405
Product Number
6
Dosage Form
-
Strength
5MG
Approval Date
2026-02-10
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78858
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
78858
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
78858
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
78858
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-05-29
Active Ingredient
LEVETIRACETAM
Application Number
91338
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2012-05-29
Active Ingredient
LEVETIRACETAM
Application Number
91338
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
90722
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-06-20
Regulatory Status
Discontinued
Drug Name
LEVOFLOXACIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
90722
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2011-06-20
Regulatory Status
Discontinued
Drug Name
LEVOFLOXACIN
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2011-06-20
Active Ingredient
LEVOFLOXACIN
Application Number
90722
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2011-06-20
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90467
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90467
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2010-10-06
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90467
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Regulatory Status
Discontinued
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
90528
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2010-10-06
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-10-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
90528
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-10-06
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-04-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
90528
Product Number
3
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-04-06
Regulatory Status
Discontinued
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208055
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208055
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208055
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
120MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208055
Product Number
4
Dosage Form
-
Strength
120MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2025-01-13
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208055
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-08-05
Active Ingredient
MACITENTAN
Application Number
211107
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-08-05
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
200155
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-10-13
Regulatory Status
Discontinued
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
200155
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2007-01-24
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
77711
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2007-01-24
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2007-01-24
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
77711
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2007-01-24
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2007-01-24
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
77711
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2007-01-24
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2010-02-18
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
79226
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2010-02-18
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2009-12-30
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
90014
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2009-12-30
Regulatory Status
Discontinued
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2000-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65062
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2000-11-30
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2000-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65062
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2000-11-30
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2000-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65062
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2000-11-30
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2004-01-06
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65156
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2004-01-06
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2004-01-06
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65156
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2004-01-06
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2004-01-06
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
65156
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2004-01-06
Regulatory Status
RX
Drug Name
MOMETASONE FUROATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2018-07-13
Active Ingredient
MOMETASONE FUROATE
Application Number
207899
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2018-07-13
Regulatory Status
RX
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2012-08-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
90984
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
90984
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
201515
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
2018-07-31
Active Ingredient
MONTELUKAST SODIUM
Application Number
210431
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/PACKET
Approval Date
2018-07-31
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2014-04-03
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
200160
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2014-04-03
Regulatory Status
Discontinued
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2018-03-02
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
203966
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2018-03-02
Regulatory Status
Discontinued
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2018-03-02
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
203966
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2018-03-02
Regulatory Status
Discontinued
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2018-03-02
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
203966
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2018-03-02
Regulatory Status
Discontinued
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2018-03-02
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
203966
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2018-03-02
Regulatory Status
Discontinued
Drug Name
NILOTINIB HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-12-15
Active Ingredient
NILOTINIB HYDROCHLORIDE
Application Number
218532
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-12-15
Regulatory Status
RX
Drug Name
NILOTINIB HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2025-12-15
Active Ingredient
NILOTINIB HYDROCHLORIDE
Application Number
218532
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2025-12-15
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2019-01-28
Active Ingredient
NYSTATIN
Application Number
211838
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2019-01-28
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2019-07-24
Active Ingredient
NYSTATIN
Application Number
212557
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2019-07-24
Regulatory Status
RX
Drug Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2020-07-14
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
213142
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2020-07-14
Regulatory Status
Discontinued
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-10-25
Active Ingredient
OLANZAPINE
Application Number
91415
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-10-25
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-10-25
Active Ingredient
OLANZAPINE
Application Number
91415
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-10-25
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2011-10-25
Active Ingredient
OLANZAPINE
Application Number
91415
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2011-10-25
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2011-10-25
Active Ingredient
OLANZAPINE
Application Number
91415
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2011-10-25
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2012-04-23
Active Ingredient
OLANZAPINE
Application Number
91434
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
91434
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
91434
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
91434
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
91434
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
91434
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2012-04-23
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
202375
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-04-24
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
202375
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-04-24
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
202375
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-04-24
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2017-05-03
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
206515
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2017-05-03
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2017-05-03
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
206515
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2017-05-03
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2017-05-03
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
206515
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2017-05-03
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;20MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
203580
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;20MG
Approval Date
2016-10-26
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;40MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
203580
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;40MG
Approval Date
2016-10-26
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;25MG;40MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
203580
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;25MG;40MG
Approval Date
2016-10-26
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;40MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
203580
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;40MG
Approval Date
2016-10-26
Regulatory Status
Discontinued
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;40MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
203580
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;40MG
Approval Date
2016-10-26
Regulatory Status
Discontinued
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2011-01-19
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
90074
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2011-01-19
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2011-01-19
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
90074
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2011-01-19
Regulatory Status
RX
Drug Name
PAZOPANIB HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2025-09-04
Active Ingredient
PAZOPANIB HYDROCHLORIDE
Application Number
219922
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2025-09-04
Regulatory Status
RX
Drug Name
PENCICLOVIR
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2023-08-07
Active Ingredient
PENCICLOVIR
Application Number
216981
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2013-02-13
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
91298
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2013-02-13
Regulatory Status
Discontinued
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-02-13
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
91298
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-02-13
Regulatory Status
Discontinued
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2013-02-13
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
91298
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2013-02-13
Regulatory Status
Discontinued
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
202001
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
202001
Product Number
2
Dosage Form
-
Strength
850MG;EQ 15MG BASE
Approval Date
2013-02-13
Regulatory Status
RX
Drug Name
POTASSIUM CITRATE
Product Number
1
Dosage Form
-
Strength
5MEQ
Approval Date
2024-02-06
Active Ingredient
POTASSIUM CITRATE
Application Number
213986
Product Number
1
Dosage Form
-
Strength
5MEQ
Approval Date
2024-02-06
Regulatory Status
Discontinued
Drug Name
POTASSIUM CITRATE
Product Number
2
Dosage Form
-
Strength
10MEQ
Approval Date
2024-02-06
Active Ingredient
POTASSIUM CITRATE
Application Number
213986
Product Number
2
Dosage Form
-
Strength
10MEQ
Approval Date
2024-02-06
Regulatory Status
Discontinued
Drug Name
POTASSIUM CITRATE
Product Number
3
Dosage Form
-
Strength
15MEQ
Approval Date
2024-02-06
Active Ingredient
POTASSIUM CITRATE
Application Number
213986
Product Number
3
Dosage Form
-
Strength
15MEQ
Approval Date
2024-02-06
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90865
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2010-10-08
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90865
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2010-10-08
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90865
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2010-10-08
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
0.75MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90865
Product Number
4
Dosage Form
-
Strength
0.75MG
Approval Date
2010-10-08
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
1MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90865
Product Number
5
Dosage Form
-
Strength
1MG
Approval Date
2010-10-08
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
1.5MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
90865
Product Number
6
Dosage Form
-
Strength
1.5MG
Approval Date
2010-10-08
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2025-02-21
Active Ingredient
PREGABALIN
Application Number
206942
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2025-02-21
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
218778
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Regulatory Status
Discontinued
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
218778
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
200363
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
200363
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
200363
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
200363
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
200363
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
200363
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Regulatory Status
Discontinued
Drug Name
RABEPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2013-11-08
Active Ingredient
RABEPRAZOLE SODIUM
Application Number
202376
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2013-11-08
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2025-02-04
Active Ingredient
RANOLAZINE
Application Number
210407
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2025-02-04
Regulatory Status
Discontinued
Drug Name
RANOLAZINE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2025-02-04
Active Ingredient
RANOLAZINE
Application Number
210407
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2025-02-04
Regulatory Status
Discontinued
Drug Name
RASAGILINE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-05-05
Active Ingredient
RASAGILINE MESYLATE
Application Number
210150
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-05-05
Regulatory Status
RX
Drug Name
RASAGILINE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-05-05
Active Ingredient
RASAGILINE MESYLATE
Application Number
210150
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-05-05
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2008-10-30
Active Ingredient
RISPERIDONE
Application Number
79088
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2008-10-30
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2008-10-30
Active Ingredient
RISPERIDONE
Application Number
79088
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2008-10-30
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2008-10-30
Active Ingredient
RISPERIDONE
Application Number
79088
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2008-10-30
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2008-10-30
Active Ingredient
RISPERIDONE
Application Number
79088
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2008-10-30
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2008-10-30
Active Ingredient
RISPERIDONE
Application Number
79088
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2008-10-30
Regulatory Status
RX
Drug Name
RISPERIDONE
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2008-10-30
Active Ingredient
RISPERIDONE
Application Number
79088
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2008-10-30
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
1
Dosage Form
-
Strength
500MCG
Approval Date
2018-08-06
Active Ingredient
ROFLUMILAST
Application Number
208272
Product Number
1
Dosage Form
-
Strength
500MCG
Approval Date
2018-08-06
Regulatory Status
Discontinued
Drug Name
ROFLUMILAST
Product Number
2
Dosage Form
-
Strength
250MCG
Approval Date
2024-10-18
Active Ingredient
ROFLUMILAST
Application Number
208272
Product Number
2
Dosage Form
-
Strength
250MCG
Approval Date
2024-10-18
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2016-10-31
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
201619
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2016-10-31
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-10-31
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
201619
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2016-10-31
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-10-31
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
201619
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2016-10-31
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-10-31
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
201619
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2016-10-31
Regulatory Status
RX
Drug Name
RUXOLITINIB
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
-
Active Ingredient
RUXOLITINIB
Application Number
220375
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RUXOLITINIB
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
-
Active Ingredient
RUXOLITINIB
Application Number
220375
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RUXOLITINIB
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
RUXOLITINIB
Application Number
220375
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RUXOLITINIB
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
RUXOLITINIB
Application Number
220375
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2024-08-22
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213604
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2024-08-22
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2024-08-22
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213604
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2024-08-22
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2024-08-22
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213604
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2024-08-22
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
77765
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Regulatory Status
Discontinued
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77765
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Regulatory Status
Discontinued
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77765
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Regulatory Status
Discontinued
Drug Name
SEVELAMER CARBONATE
Product Number
1
Dosage Form
-
Strength
800MG/PACKET
Approval Date
2025-02-27
Active Ingredient
SEVELAMER CARBONATE
Application Number
215909
Product Number
1
Dosage Form
-
Strength
800MG/PACKET
Approval Date
2025-02-27
Regulatory Status
Discontinued
Drug Name
SEVELAMER CARBONATE
Product Number
2
Dosage Form
-
Strength
2.4GM/PACKET
Approval Date
2025-02-27
Active Ingredient
SEVELAMER CARBONATE
Application Number
215909
Product Number
2
Dosage Form
-
Strength
2.4GM/PACKET
Approval Date
2025-02-27
Regulatory Status
Discontinued
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-06-11
Active Ingredient
SILDENAFIL CITRATE
Application Number
91448
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
91448
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
91448
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
2012-11-06
Active Ingredient
SILDENAFIL CITRATE
Application Number
91479
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-11-06
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2025-02-10
Active Ingredient
SILODOSIN
Application Number
210396
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2025-02-10
Regulatory Status
Discontinued
Drug Name
SILODOSIN
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2025-02-10
Active Ingredient
SILODOSIN
Application Number
210396
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2025-02-10
Regulatory Status
Discontinued
Drug Name
SOLIFENACIN SUCCINATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-03-04
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
209424
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-03-04
Regulatory Status
Discontinued
Drug Name
SOLIFENACIN SUCCINATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-03-04
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
209424
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-03-04
Regulatory Status
Discontinued
Drug Name
SORAFENIB TOSYLATE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2023-04-12
Active Ingredient
SORAFENIB TOSYLATE
Application Number
217095
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2023-04-12
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
211839
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
211839
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
211839
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
211839
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
2019-03-26
Active Ingredient
TADALAFIL
Application Number
212062
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2026-05-20
Active Ingredient
TADALAFIL
Application Number
212062
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
203171
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-07-07
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
203171
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2014-07-07
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
203171
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2014-07-07
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2014-01-08
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202517
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2014-01-08
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2014-01-08
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202517
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2014-01-08
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2014-01-08
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202517
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2014-01-08
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2014-01-08
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202517
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2014-01-08
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2014-02-25
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
201192
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2014-02-25
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2014-02-25
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
201192
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2014-02-25
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2014-02-25
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
201192
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2014-02-25
Regulatory Status
Discontinued
Drug Name
TOLTERODINE TARTRATE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-08-11
Active Ingredient
TOLTERODINE TARTRATE
Application Number
203016
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-08-11
Regulatory Status
RX
Drug Name
TOLTERODINE TARTRATE
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2015-08-11
Active Ingredient
TOLTERODINE TARTRATE
Application Number
203016
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2015-08-11
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
79153
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2009-03-27
Regulatory Status
Discontinued
Drug Name
TOPIRAMATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
79153
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2009-03-27
Regulatory Status
Discontinued
Drug Name
TOPIRAMATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
79153
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2009-03-27
Regulatory Status
Discontinued
Drug Name
TOPIRAMATE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-03-27
Active Ingredient
TOPIRAMATE
Application Number
79153
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2009-03-27
Regulatory Status
Discontinued
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2013-11-27
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
202180
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2013-11-27
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2013-11-27
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
202180
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2013-11-27
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2013-11-27
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
202180
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2013-11-27
Regulatory Status
RX
Drug Name
TRAZODONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2013-11-27
Active Ingredient
TRAZODONE HYDROCHLORIDE
Application Number
202180
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2013-11-27
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202728
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Regulatory Status
Discontinued
Drug Name
VALSARTAN
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202728
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2015-01-05
Regulatory Status
Discontinued
Drug Name
VALSARTAN
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202728
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2015-01-05
Regulatory Status
Discontinued
Drug Name
VALSARTAN
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
202728
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Regulatory Status
Discontinued
Drug Name
VALSARTAN; HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
80MG; 12.5MG
Approval Date
-
Active Ingredient
VALSARTAN; HYDROCHLOROTHIAZIDE
Application Number
91654
Product Number
1
Dosage Form
-
Strength
80MG; 12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VALSARTAN; HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
160MG; 12.5MG
Approval Date
-
Active Ingredient
VALSARTAN; HYDROCHLOROTHIAZIDE
Application Number
91654
Product Number
2
Dosage Form
-
Strength
160MG; 12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VALSARTAN; HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
160MG; 25MG
Approval Date
-
Active Ingredient
VALSARTAN; HYDROCHLOROTHIAZIDE
Application Number
91654
Product Number
3
Dosage Form
-
Strength
160MG; 25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VALSARTAN; HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
320MG; 12.5MG
Approval Date
-
Active Ingredient
VALSARTAN; HYDROCHLOROTHIAZIDE
Application Number
91654
Product Number
4
Dosage Form
-
Strength
320MG; 12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VALSARTAN; HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
320MG; 25MG
Approval Date
-
Active Ingredient
VALSARTAN; HYDROCHLOROTHIAZIDE
Application Number
91654
Product Number
5
Dosage Form
-
Strength
320MG; 25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2011-06-01
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90899
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2011-06-01
Regulatory Status
Discontinued
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2011-06-01
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90899
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2011-06-01
Regulatory Status
Discontinued
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2011-06-01
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
90899
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2011-06-01
Regulatory Status
Discontinued
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2025-01-28
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
218180
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2025-01-28
Regulatory Status
Discontinued
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-01-28
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
218180
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-01-28
Regulatory Status
Discontinued
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-01-28
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
218180
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-01-28
Regulatory Status
Discontinued
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 225MG BASE
Approval Date
2025-01-28
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
218180
Product Number
4
Dosage Form
-
Strength
EQ 225MG BASE
Approval Date
2025-01-28
Regulatory Status
Discontinued
Drug Name
VENXXIVA
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2024-01-30
Active Ingredient
TIOPRONIN
Application Number
216990
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2024-01-30
Regulatory Status
RX
Drug Name
VENXXIVA
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2024-01-30
Active Ingredient
TIOPRONIN
Application Number
216990
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2024-01-30
Regulatory Status
RX
Drug Name
VERICIGUAT
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
-
Active Ingredient
VERICIGUAT
Application Number
220221
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VERICIGUAT
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
VERICIGUAT
Application Number
220221
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZOLPIDEM TARTRATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-08-17
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
77903
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-08-17
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-08-17
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
77903
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-08-17
Regulatory Status
RX
Drug Status Breakdown
326 total- Discontinued
- RX
- Unclassified
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
ACETAZOLAMIDE
Application Number
213706
Product Number
1
Active Ingredient
ACETAZOLAMIDE
Dosage Form
-
Strength
125MG
FDA Approved Drug Data
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