Viatris
FDA Approved Drugs
Viatris
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 922
- Latest Approval Date Jul 28, 2026
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Overview
Social Profiles
Company Snapshot
Viatris
Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
U.S.A
www.viatris.com/en HRServiceCenter@Viatris.com View on MapFDA Approved Drug Records ( 922 records )
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-06-18
Active Ingredient
ABACAVIR SULFATE
Application Number
91294
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-06-18
Regulatory Status
RX
Drug Name
ABACAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
60 MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE
Application Number
200733
Product Number
1
Dosage Form
-
Strength
60 MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABACAVIR SULFATE; LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
600MG; 300MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
90519
Product Number
1
Dosage Form
-
Strength
600MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABACAVIR SULFATE; LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
60MG; 30MG
Approval Date
-
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
202381
Product Number
1
Dosage Form
-
Strength
60MG; 30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABIRATERONE ACETATE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2018-10-31
Active Ingredient
ABIRATERONE ACETATE
Application Number
208446
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2018-10-31
Regulatory Status
RX
Drug Name
ABIRATERONE ACETATE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-12-14
Active Ingredient
ABIRATERONE ACETATE
Application Number
208446
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2020-12-14
Regulatory Status
RX
Drug Name
ACAMPROSATE CALCIUM
Product Number
1
Dosage Form
-
Strength
333MG
Approval Date
2014-03-11
Active Ingredient
ACAMPROSATE CALCIUM
Application Number
200142
Product Number
1
Dosage Form
-
Strength
333MG
Approval Date
2014-03-11
Regulatory Status
RX
Drug Name
ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2020-08-07
Active Ingredient
ACETAMINOPHEN
Application Number
213255
Product Number
1
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2020-08-07
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-09-10
Active Ingredient
ACITRETIN
Application Number
202148
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-09-10
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-10
Active Ingredient
ACITRETIN
Application Number
202148
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-10
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
1
Dosage Form
-
Strength
17.5MG
Approval Date
2015-09-10
Active Ingredient
ACITRETIN
Application Number
203707
Product Number
1
Dosage Form
-
Strength
17.5MG
Approval Date
2015-09-10
Regulatory Status
Discontinued
Drug Name
ACITRETIN
Product Number
2
Dosage Form
-
Strength
22.5MG
Approval Date
2015-09-10
Active Ingredient
ACITRETIN
Application Number
203707
Product Number
2
Dosage Form
-
Strength
22.5MG
Approval Date
2015-09-10
Regulatory Status
Discontinued
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1998-04-13
Active Ingredient
ACYCLOVIR
Application Number
74976
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1998-04-13
Regulatory Status
Discontinued
Drug Name
ACYCLOVIR
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1998-04-13
Active Ingredient
ACYCLOVIR
Application Number
74976
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1998-04-13
Regulatory Status
Discontinued
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1998-04-13
Active Ingredient
ACYCLOVIR
Application Number
74977
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1998-04-13
Regulatory Status
Discontinued
Drug Name
ADENOSINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2009-05-13
Active Ingredient
ADENOSINE
Application Number
78686
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2009-05-13
Regulatory Status
RX
Drug Name
ALENDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 35MG BASE
Approval Date
2008-08-04
Active Ingredient
ALENDRONATE SODIUM
Application Number
78638
Product Number
1
Dosage Form
-
Strength
EQ 35MG BASE
Approval Date
2008-08-04
Regulatory Status
Discontinued
Drug Name
ALENDRONATE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 70MG BASE
Approval Date
2008-08-04
Active Ingredient
ALENDRONATE SODIUM
Application Number
78638
Product Number
2
Dosage Form
-
Strength
EQ 70MG BASE
Approval Date
2008-08-04
Regulatory Status
Discontinued
Drug Name
ALLOPURINOL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1986-10-24
Active Ingredient
ALLOPURINOL
Application Number
18659
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1986-10-24
Regulatory Status
RX
Drug Name
ALLOPURINOL
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1986-10-24
Active Ingredient
ALLOPURINOL
Application Number
18659
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1986-10-24
Regulatory Status
RX
Drug Name
ALMOTRIPTAN MALATE
Product Number
1
Dosage Form
-
Strength
EQ 6.25MG BASE
Approval Date
2015-11-09
Active Ingredient
ALMOTRIPTAN MALATE
Application Number
205171
Product Number
1
Dosage Form
-
Strength
EQ 6.25MG BASE
Approval Date
2015-11-09
Regulatory Status
RX
Drug Name
ALMOTRIPTAN MALATE
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2015-11-09
Active Ingredient
ALMOTRIPTAN MALATE
Application Number
205171
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2015-11-09
Regulatory Status
RX
Drug Name
ALOPRIM
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1996-05-17
Active Ingredient
ALLOPURINOL SODIUM
Application Number
20298
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
1996-05-17
Regulatory Status
RX
Drug Name
ALPRAZOLAM
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1994-01-27
Active Ingredient
ALPRAZOLAM
Application Number
74215
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
1994-01-27
Regulatory Status
Discontinued
Drug Name
ALPRAZOLAM
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1994-01-27
Active Ingredient
ALPRAZOLAM
Application Number
74215
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
1994-01-27
Regulatory Status
Discontinued
Drug Name
ALPRAZOLAM
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
1994-01-27
Active Ingredient
ALPRAZOLAM
Application Number
74215
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
1994-01-27
Regulatory Status
Discontinued
Drug Name
ALPRAZOLAM
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
1994-01-27
Active Ingredient
ALPRAZOLAM
Application Number
74215
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
1994-01-27
Regulatory Status
Discontinued
Drug Name
AMBRISENTAN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-03-28
Active Ingredient
AMBRISENTAN
Application Number
208441
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-03-28
Regulatory Status
RX
Drug Name
AMBRISENTAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-03-28
Active Ingredient
AMBRISENTAN
Application Number
208441
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-03-28
Regulatory Status
RX
Drug Name
AMIODARONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2002-10-15
Active Ingredient
AMIODARONE HYDROCHLORIDE
Application Number
76217
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2002-10-15
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86010
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86011
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86153
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86157
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
86158
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG/20MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
1
Dosage Form
-
Strength
5MG/20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
5MG/40MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
2
Dosage Form
-
Strength
5MG/40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
10MG/20MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
3
Dosage Form
-
Strength
10MG/20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
10MG/40MG
Approval Date
-
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
90398
Product Number
4
Dosage Form
-
Strength
10MG/40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
AMLODIPINE BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2005-10-03
Active Ingredient
AMLODIPINE BESYLATE
Application Number
76418
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2005-10-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-10-03
Active Ingredient
AMLODIPINE BESYLATE
Application Number
76418
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-10-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2005-10-03
Active Ingredient
AMLODIPINE BESYLATE
Application Number
76418
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2005-10-03
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Regulatory Status
Discontinued
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
6
Dosage Form
-
Strength
EQ 5MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
6
Dosage Form
-
Strength
EQ 5MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
8
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
8
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
9
Dosage Form
-
Strength
EQ 10MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
9
Dosage Form
-
Strength
EQ 10MG BASE;EQ 20MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
10
Dosage Form
-
Strength
EQ 10MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
10
Dosage Form
-
Strength
EQ 10MG BASE;EQ 40MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
11
Dosage Form
-
Strength
EQ 10MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
200465
Product Number
11
Dosage Form
-
Strength
EQ 10MG BASE;EQ 80MG BASE
Approval Date
2013-11-29
Regulatory Status
RX
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
90483
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
90483
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-03-30
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
90483
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-03-30
Regulatory Status
RX
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
90483
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-03-30
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-11-08
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-11-08
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2002-11-08
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2002-11-08
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2002-11-08
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2002-11-08
Regulatory Status
RX
Drug Name
AMNESTEEM
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2025-03-17
Active Ingredient
ISOTRETINOIN
Application Number
75945
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2025-03-17
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62067
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62067
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62090
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
1982-01-01
Active Ingredient
AMOXICILLIN
Application Number
62090
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMPHOTERICIN B
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2025-06-30
Active Ingredient
AMPHOTERICIN B
Application Number
212967
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2025-06-30
Regulatory Status
RX
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
61755
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
61755
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
61829
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
AMPICILLIN TRIHYDRATE
Product Number
2
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
AMPICILLIN/AMPICILLIN TRIHYDRATE
Application Number
61829
Product Number
2
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
APIXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-12-23
Active Ingredient
APIXABAN
Application Number
210128
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-12-23
Regulatory Status
Discontinued
Drug Name
APIXABAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-12-23
Active Ingredient
APIXABAN
Application Number
210128
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-12-23
Regulatory Status
Discontinued
Drug Name
APREPITANT
Product Number
1
Dosage Form
-
Strength
32MG/4.4ML (7.2MG/ML)
Approval Date
2026-03-05
Active Ingredient
APREPITANT
Application Number
218851
Product Number
1
Dosage Form
-
Strength
32MG/4.4ML (7.2MG/ML)
Approval Date
2026-03-05
Regulatory Status
Discontinued
Drug Name
AQUATENSEN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
METHYCLOTHIAZIDE
Application Number
17364
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ARGATROBAN
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2014-06-30
Active Ingredient
ARGATROBAN
Application Number
202626
Product Number
1
Dosage Form
-
Strength
250MG/2.5ML (100MG/ML)
Approval Date
2014-06-30
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
300MG/VIAL
Approval Date
2024-12-03
Active Ingredient
ARIPIPRAZOLE
Application Number
216608
Product Number
1
Dosage Form
-
Strength
300MG/VIAL
Approval Date
2024-12-03
Regulatory Status
Discontinued
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
400MG/VIAL
Approval Date
2024-12-03
Active Ingredient
ARIPIPRAZOLE
Application Number
216608
Product Number
2
Dosage Form
-
Strength
400MG/VIAL
Approval Date
2024-12-03
Regulatory Status
Discontinued
Drug Name
ARMODAFINIL
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2012-06-01
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-06-01
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2012-06-01
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-05-09
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-05-09
Regulatory Status
RX
Drug Name
ARMODAFINIL
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2019-05-09
Active Ingredient
ARMODAFINIL
Application Number
200043
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2019-05-09
Regulatory Status
RX
Drug Name
ASTEPRO
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-10-15
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
22203
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2008-10-15
Regulatory Status
Discontinued
Drug Name
ASTEPRO
Product Number
2
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2009-08-31
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
22203
Product Number
2
Dosage Form
-
Strength
0.2055MG/SPRAY
Approval Date
2009-08-31
Regulatory Status
Discontinued
Drug Name
ATAZANAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
ATAZANAVIR SULFATE
Application Number
91611
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ATAZANAVIR SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-09-24
Active Ingredient
ATAZANAVIR SULFATE
Application Number
208177
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-09-24
Regulatory Status
Discontinued
Drug Name
ATAZANAVIR SULFATE
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2018-09-24
Active Ingredient
ATAZANAVIR SULFATE
Application Number
208177
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2018-09-24
Regulatory Status
Discontinued
Drug Name
ATAZANAVIR SULFATE
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-09-24
Active Ingredient
ATAZANAVIR SULFATE
Application Number
208177
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-09-24
Regulatory Status
Discontinued
Drug Name
ATAZANAVIR SULFATE AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
300MG/100MG
Approval Date
-
Active Ingredient
ATAZANAVIR SULFATE; RITONAVIR
Application Number
22282
Product Number
1
Dosage Form
-
Strength
300MG/100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ATENOLOL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1992-01-24
Active Ingredient
ATENOLOL
Application Number
73457
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1992-01-24
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1999-04-26
Active Ingredient
ATENOLOL
Application Number
73457
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1999-04-26
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1992-01-24
Active Ingredient
ATENOLOL
Application Number
73457
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1992-01-24
Regulatory Status
RX
Drug Name
ATENOLOL
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1994-03-23
Active Ingredient
ATENOLOL
Application Number
74126
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1994-03-23
Regulatory Status
Discontinued
Drug Name
ATENOLOL
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1994-03-23
Active Ingredient
ATENOLOL
Application Number
74126
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1994-03-23
Regulatory Status
Discontinued
Drug Name
ATENOLOL
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1998-08-26
Active Ingredient
ATENOLOL
Application Number
74126
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1998-08-26
Regulatory Status
Discontinued
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2012-05-29
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
91226
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2012-05-29
Regulatory Status
RX
Drug Name
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
62.5MG;25MG
Approval Date
2014-05-27
Active Ingredient
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Application Number
202362
Product Number
1
Dosage Form
-
Strength
62.5MG;25MG
Approval Date
2014-05-27
Regulatory Status
RX
Drug Name
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
250MG;100MG
Approval Date
2014-05-27
Active Ingredient
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Application Number
202362
Product Number
2
Dosage Form
-
Strength
250MG;100MG
Approval Date
2014-05-27
Regulatory Status
RX
Drug Name
AVITA
Product Number
3
Dosage Form
-
Strength
0.025%
Approval Date
1997-01-14
Active Ingredient
TRETINOIN
Application Number
20404
Product Number
3
Dosage Form
-
Strength
0.025%
Approval Date
1997-01-14
Regulatory Status
RX
Drug Name
BALSALAZIDE DISODIUM
Product Number
1
Dosage Form
-
Strength
1.1G
Approval Date
-
Active Ingredient
BALSALAZIDE DISODIUM
Application Number
206909
Product Number
1
Dosage Form
-
Strength
1.1G
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76612
Product Number
1
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2004-02-11
Regulatory Status
Discontinued
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76612
Product Number
2
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2004-02-11
Regulatory Status
Discontinued
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76612
Product Number
3
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2004-02-11
Regulatory Status
Discontinued
Drug Name
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
20MG;25MG
Approval Date
2004-02-11
Active Ingredient
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Application Number
76612
Product Number
4
Dosage Form
-
Strength
20MG;25MG
Approval Date
2004-02-11
Regulatory Status
Discontinued
Drug Name
BEPADIN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1990-12-28
Active Ingredient
BEPRIDIL HYDROCHLORIDE
Application Number
19001
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1990-12-28
Regulatory Status
Discontinued
Drug Name
BEPADIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1990-12-28
Active Ingredient
BEPRIDIL HYDROCHLORIDE
Application Number
19001
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1990-12-28
Regulatory Status
Discontinued
Drug Name
BEPADIN
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1990-12-28
Active Ingredient
BEPRIDIL HYDROCHLORIDE
Application Number
19001
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1990-12-28
Regulatory Status
Discontinued
Drug Name
BEPOTASTINE BESILATE
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2019-03-18
Active Ingredient
BEPOTASTINE BESILATE
Application Number
206220
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2019-03-18
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
2.5MG;6.25MG
Approval Date
2000-09-25
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
75768
Product Number
1
Dosage Form
-
Strength
2.5MG;6.25MG
Approval Date
2000-09-25
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2000-09-25
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
75768
Product Number
2
Dosage Form
-
Strength
5MG;6.25MG
Approval Date
2000-09-25
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
10MG;6.25MG
Approval Date
2000-09-25
Active Ingredient
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
Application Number
75768
Product Number
3
Dosage Form
-
Strength
10MG;6.25MG
Approval Date
2000-09-25
Regulatory Status
RX
Drug Name
BIVALIRUDIN
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
2018-06-01
Active Ingredient
BIVALIRUDIN
Application Number
202471
Product Number
1
Dosage Form
-
Strength
250MG/VIAL
Approval Date
2018-06-01
Regulatory Status
RX
Drug Name
BOSENTAN
Product Number
1
Dosage Form
-
Strength
62.5MG
Approval Date
2020-01-15
Active Ingredient
BOSENTAN
Application Number
205173
Product Number
1
Dosage Form
-
Strength
62.5MG
Approval Date
2020-01-15
Regulatory Status
Discontinued
Drug Name
BOSENTAN
Product Number
2
Dosage Form
-
Strength
125MG
Approval Date
2020-01-15
Active Ingredient
BOSENTAN
Application Number
205173
Product Number
2
Dosage Form
-
Strength
125MG
Approval Date
2020-01-15
Regulatory Status
Discontinued
Drug Name
BREYNA
Product Number
1
Dosage Form
-
Strength
0.08MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Active Ingredient
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Application Number
211699
Product Number
1
Dosage Form
-
Strength
0.08MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Regulatory Status
RX
Drug Name
BREYNA
Product Number
2
Dosage Form
-
Strength
0.16MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Active Ingredient
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
Application Number
211699
Product Number
2
Dosage Form
-
Strength
0.16MG/INH;0.0045MG/INH
Approval Date
2022-03-15
Regulatory Status
RX
Drug Name
BROMOCRIPTINE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-04-04
Active Ingredient
BROMOCRIPTINE MESYLATE
Application Number
77226
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-04-04
Regulatory Status
RX
Drug Name
BUDESONIDE
Product Number
1
Dosage Form
-
Strength
9MG
Approval Date
2020-09-17
Active Ingredient
BUDESONIDE
Application Number
208851
Product Number
1
Dosage Form
-
Strength
9MG
Approval Date
2020-09-17
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2018-06-14
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
207607
Product Number
1
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2018-06-14
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE;EQ 3MG BASE
Approval Date
2018-06-14
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
207607
Product Number
2
Dosage Form
-
Strength
EQ 12MG BASE;EQ 3MG BASE
Approval Date
2018-06-14
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Approval Date
2020-04-17
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
211785
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE;EQ 0.5MG BASE
Approval Date
2020-04-17
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE;EQ 1MG BASE
Approval Date
2020-04-17
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Application Number
211785
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE;EQ 1MG BASE
Approval Date
2020-04-17
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2002-02-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
75467
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2002-02-28
Regulatory Status
Discontinued
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
7.5MG
Approval Date
2001-03-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
75467
Product Number
2
Dosage Form
-
Strength
7.5MG
Approval Date
2001-03-28
Regulatory Status
Discontinued
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2002-02-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
75467
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2002-02-28
Regulatory Status
Discontinued
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2002-02-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
75467
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2002-02-28
Regulatory Status
Discontinued
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2001-06-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2001-06-28
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
7.5MG
Approval Date
2013-07-08
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
2
Dosage Form
-
Strength
7.5MG
Approval Date
2013-07-08
Regulatory Status
Discontinued
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2002-03-01
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2002-03-01
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2002-03-01
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2002-03-01
Regulatory Status
RX
Drug Name
BUSPIRONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2001-03-28
Active Ingredient
BUSPIRONE HYDROCHLORIDE
Application Number
76008
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2001-03-28
Regulatory Status
RX
Drug Name
BUSULFAN
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2017-11-20
Active Ingredient
BUSULFAN
Application Number
208536
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2017-11-20
Regulatory Status
Discontinued
Drug Name
BUTICAPS
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
85381
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BUTICAPS
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
85381
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BUTICAPS
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
85381
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
BUTICAPS
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
BUTABARBITAL SODIUM
Application Number
85381
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CABAZITAXEL
Product Number
1
Dosage Form
-
Strength
60MG/1.5ML (40MG/ML)
Approval Date
2023-07-05
Active Ingredient
CABAZITAXEL
Application Number
207381
Product Number
1
Dosage Form
-
Strength
60MG/1.5ML (40MG/ML)
Approval Date
2023-07-05
Regulatory Status
Discontinued
Drug Name
CANDESARTAN CILEXETIL
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
4
Dosage Form
-
Strength
32MG
Approval Date
2013-05-03
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
78702
Product Number
4
Dosage Form
-
Strength
32MG
Approval Date
2013-05-03
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
1
Dosage Form
-
Strength
50MG;200MG
Approval Date
1999-09-30
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
75091
Product Number
1
Dosage Form
-
Strength
50MG;200MG
Approval Date
1999-09-30
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2000-04-21
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
75091
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2000-04-21
Regulatory Status
RX
Drug Name
CARDURA
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA
Product Number
4
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
1990-11-02
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
19668
Product Number
4
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
1990-11-02
Regulatory Status
RX
Drug Name
CARDURA XL
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2005-02-22
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
21269
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2005-02-22
Regulatory Status
RX
Drug Name
CARDURA XL
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2005-02-22
Active Ingredient
DOXAZOSIN MESYLATE
Application Number
21269
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2005-02-22
Regulatory Status
RX
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-12-27
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
76677
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-12-27
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE ALLERGY
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-12-27
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
76677
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-12-27
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2007-12-27
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
76677
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2007-12-27
Regulatory Status
OTC
Drug Name
CETIRIZINE HYDROCHLORIDE HIVES
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2007-12-27
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
76677
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2007-12-27
Regulatory Status
OTC
Drug Name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Application Number
71296
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE;10MG
Approval Date
1986-12-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Application Number
71297
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE;10MG
Approval Date
1986-12-10
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
1986-12-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Application Number
71297
Product Number
2
Dosage Form
-
Strength
EQ 12.5MG BASE;5MG
Approval Date
1986-12-10
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE
Application Number
84601
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE
Application Number
84886
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE
Application Number
84887
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
CHLORTHALIDONE
Application Number
86831
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
CHLORTHALIDONE
Application Number
86831
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
CICLOPIROX
Product Number
1
Dosage Form
-
Strength
8%
Approval Date
2007-09-18
Active Ingredient
CICLOPIROX
Application Number
78567
Product Number
1
Dosage Form
-
Strength
8%
Approval Date
2007-09-18
Regulatory Status
Discontinued
Drug Name
CIDOFOVIR
Product Number
1
Dosage Form
-
Strength
EQ 375MG BASE/5ML (EQ 75MG BASE/ML)
Approval Date
2012-06-27
Active Ingredient
CIDOFOVIR
Application Number
201276
Product Number
1
Dosage Form
-
Strength
EQ 375MG BASE/5ML (EQ 75MG BASE/ML)
Approval Date
2012-06-27
Regulatory Status
RX
Drug Name
CIMDUO
Product Number
1
Dosage Form
-
Strength
300MG;300MG
Approval Date
2018-02-28
Active Ingredient
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
22141
Product Number
1
Dosage Form
-
Strength
300MG;300MG
Approval Date
2018-02-28
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CIMETIDINE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
1994-05-17
Active Ingredient
CIMETIDINE
Application Number
74246
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
1994-05-17
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2004-11-05
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77042
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2004-11-05
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77042
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CITALOPRAM HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2004-11-05
Active Ingredient
CITALOPRAM HYDROBROMIDE
Application Number
77042
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2004-11-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
Product Number
1
Dosage Form
-
Strength
5%;EQ 1% BASE
Approval Date
2009-08-11
Active Ingredient
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Application Number
65443
Product Number
1
Dosage Form
-
Strength
5%;EQ 1% BASE
Approval Date
2009-08-11
Regulatory Status
RX
Drug Name
CLONIDINE
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2010-07-16
Active Ingredient
CLONIDINE
Application Number
76166
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2010-07-16
Regulatory Status
RX
Drug Name
CLONIDINE
Product Number
2
Dosage Form
-
Strength
0.2MG/24HR
Approval Date
2010-07-16
Active Ingredient
CLONIDINE
Application Number
76166
Product Number
2
Dosage Form
-
Strength
0.2MG/24HR
Approval Date
2010-07-16
Regulatory Status
RX
Drug Name
CLONIDINE
Product Number
3
Dosage Form
-
Strength
0.3MG/24HR
Approval Date
2010-07-16
Active Ingredient
CLONIDINE
Application Number
76166
Product Number
3
Dosage Form
-
Strength
0.3MG/24HR
Approval Date
2010-07-16
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1999-05-27
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1999-05-27
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1999-05-27
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
1999-05-27
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
3
Dosage Form
-
Strength
12.5MG
Approval Date
2010-04-15
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
3
Dosage Form
-
Strength
12.5MG
Approval Date
2010-04-15
Regulatory Status
Discontinued
Drug Name
CLOZAPINE
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2010-04-15
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
2010-04-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2010-04-15
Active Ingredient
CLOZAPINE
Application Number
75417
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2010-04-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CLOZAPINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-15
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2015-09-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2015-09-15
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2015-09-15
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
2023-08-07
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
4
Dosage Form
-
Strength
150MG
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
CLOZAPINE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-08-07
Active Ingredient
CLOZAPINE
Application Number
201824
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
COBICISTAT
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2024-02-07
Active Ingredient
COBICISTAT
Application Number
209986
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2024-02-07
Regulatory Status
Discontinued
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2019-09-16
Active Ingredient
COLCHICINE
Application Number
209470
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2019-09-16
Regulatory Status
RX
Drug Name
COLONAID
Product Number
1
Dosage Form
-
Strength
0.025MG/5ML;2.5MG/5ML
Approval Date
1982-01-01
Active Ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Application Number
85735
Product Number
1
Dosage Form
-
Strength
0.025MG/5ML;2.5MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
COLONAID
Product Number
1
Dosage Form
-
Strength
0.025MG;2.5MG
Approval Date
1982-01-01
Active Ingredient
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
Application Number
85737
Product Number
1
Dosage Form
-
Strength
0.025MG;2.5MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CORTIFOAM
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
1982-02-10
Active Ingredient
HYDROCORTISONE ACETATE
Application Number
17351
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
1982-02-10
Regulatory Status
RX
Drug Name
CYANOCOBALAMIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2003-09-23
Active Ingredient
CYANOCOBALAMIN
Application Number
40451
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2003-09-23
Regulatory Status
Discontinued
Drug Name
CYCLOSPORINE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-02-02
Active Ingredient
CYCLOSPORINE
Application Number
205894
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-02-02
Regulatory Status
RX
Drug Name
CYPROHEPTADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Active Ingredient
CYPROHEPTADINE HYDROCHLORIDE
Application Number
86678
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
CYSTAGON
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1994-08-15
Active Ingredient
CYSTEAMINE BITARTRATE
Application Number
20392
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1994-08-15
Regulatory Status
RX
Drug Name
CYSTAGON
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1994-08-15
Active Ingredient
CYSTEAMINE BITARTRATE
Application Number
20392
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1994-08-15
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-02-03
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208067
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2025-02-03
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-02-03
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208067
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-02-03
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2022-02-04
Active Ingredient
DAPSONE
Application Number
213847
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2022-02-04
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2018-06-05
Active Ingredient
DAPTOMYCIN
Application Number
205037
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2018-06-05
Regulatory Status
RX
Drug Name
DAPTOMYCIN
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-08-07
Active Ingredient
DAPTOMYCIN
Application Number
213966
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
5
Dosage Form
-
Strength
600MG
Approval Date
2025-07-22
Active Ingredient
DARUNAVIR
Application Number
202136
Product Number
5
Dosage Form
-
Strength
600MG
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
DARUNAVIR AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
400MG/50MG
Approval Date
-
Active Ingredient
DARUNAVIR AND RITONAVIR
Application Number
209847
Product Number
1
Dosage Form
-
Strength
400MG/50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DENAVIR
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1996-09-24
Active Ingredient
PENCICLOVIR
Application Number
20629
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
1996-09-24
Regulatory Status
RX
Drug Name
DEPEN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
PENICILLAMINE
Application Number
19854
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2008-08-29
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
40802
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2008-08-29
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
2008-08-29
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
40803
Product Number
1
Dosage Form
-
Strength
EQ 4MG PHOSPHATE/ML
Approval Date
2008-08-29
Regulatory Status
RX
Drug Name
DEXLANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2024-01-19
Active Ingredient
DEXLANSOPRAZOLE
Application Number
205205
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2024-01-19
Regulatory Status
RX
Drug Name
DEXLANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2024-01-19
Active Ingredient
DEXLANSOPRAZOLE
Application Number
205205
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2024-01-19
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2014-08-18
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
202881
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Approval Date
2014-08-18
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
212571
Product Number
1
Dosage Form
-
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Regulatory Status
RX
Drug Name
DEXMEDETOMIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Active Ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Application Number
212571
Product Number
2
Dosage Form
-
Strength
EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Approval Date
2020-08-27
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1985-09-04
Active Ingredient
DIAZEPAM
Application Number
70325
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1985-09-04
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1985-09-04
Active Ingredient
DIAZEPAM
Application Number
70325
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
1985-09-04
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1985-09-04
Active Ingredient
DIAZEPAM
Application Number
70325
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
1985-09-04
Regulatory Status
RX
Drug Name
DIFLUPREDNATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2025-03-20
Active Ingredient
DIFLUPREDNATE
Application Number
212566
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2025-03-20
Regulatory Status
RX
Drug Name
DILANTIN
Product Number
1
Dosage Form
-
Strength
30MG EXTENDED
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN SODIUM
Application Number
84349
Product Number
1
Dosage Form
-
Strength
30MG EXTENDED
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DILANTIN
Product Number
2
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN SODIUM
Application Number
84349
Product Number
2
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DILANTIN-125
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN
Application Number
8762
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
DILANTIN-30
Product Number
2
Dosage Form
-
Strength
30MG/5ML
Approval Date
1982-01-01
Active Ingredient
PHENYTOIN
Application Number
8762
Product Number
2
Dosage Form
-
Strength
30MG/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1997-05-02
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
74910
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1997-05-02
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
1997-05-02
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
74910
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
1997-05-02
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
1997-05-02
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
74910
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
1997-05-02
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1999-09-30
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
75375
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1999-09-30
Regulatory Status
Discontinued
Drug Name
DIMETHYL FUMARATE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2020-08-17
Active Ingredient
DIMETHYL FUMARATE
Application Number
210531
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2020-08-17
Regulatory Status
Discontinued
Drug Name
DIMETHYL FUMARATE
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2020-08-17
Active Ingredient
DIMETHYL FUMARATE
Application Number
210531
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2020-08-17
Regulatory Status
Discontinued
Drug Name
DIMETHYL SULFOXIDE
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
2002-11-29
Active Ingredient
DIMETHYL SULFOXIDE
Application Number
76185
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
2002-11-29
Regulatory Status
Discontinued
Drug Name
DISOPYRAMIDE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1985-06-14
Active Ingredient
DISOPYRAMIDE PHOSPHATE
Application Number
70138
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1985-06-14
Regulatory Status
Discontinued
Drug Name
DISOPYRAMIDE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1985-06-14
Active Ingredient
DISOPYRAMIDE PHOSPHATE
Application Number
70139
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1985-06-14
Regulatory Status
Discontinued
Drug Name
DIUTENSEN-R
Product Number
5
Dosage Form
-
Strength
2.5MG;0.1MG
Approval Date
1982-01-01
Active Ingredient
METHYCLOTHIAZIDE; RESERPINE
Application Number
12708
Product Number
5
Dosage Form
-
Strength
2.5MG;0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2008-07-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77254
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2008-07-29
Regulatory Status
Discontinued
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2008-07-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77254
Product Number
2
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2008-07-29
Regulatory Status
Discontinued
Drug Name
DIVALPROEX SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2008-07-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77254
Product Number
3
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2008-07-29
Regulatory Status
Discontinued
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2009-01-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77567
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2009-01-29
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2009-01-29
Active Ingredient
DIVALPROEX SODIUM
Application Number
77567
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2009-01-29
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
160MG/8ML (20MG/ML)
Approval Date
2019-04-01
Active Ingredient
DOCETAXEL
Application Number
208137
Product Number
1
Dosage Form
-
Strength
160MG/8ML (20MG/ML)
Approval Date
2019-04-01
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2018-04-30
Active Ingredient
DOCETAXEL
Application Number
208859
Product Number
1
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2018-04-30
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2018-07-02
Active Ingredient
DOCETAXEL
Application Number
210072
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2018-07-02
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2018-07-06
Active Ingredient
DOCETAXEL
Application Number
210848
Product Number
1
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2018-07-06
Regulatory Status
RX
Drug Name
DOLUTEGRAVIR, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
50MG;300MG;300MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
Application Number
209670
Product Number
1
Dosage Form
-
Strength
50MG;300MG;300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DORMATE
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1982-01-01
Active Ingredient
MEBUTAMATE
Application Number
17374
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70790
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-05-13
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70791
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-05-13
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
-
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70792
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
70793
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2011-10-28
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
200170
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2011-10-28
Regulatory Status
Discontinued
Drug Name
DOXORUBICIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2011-10-28
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
200170
Product Number
2
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2011-10-28
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
-
Active Ingredient
DOXYCYCLINE
Application Number
90855
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2012-08-21
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
91406
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2012-08-21
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1983-02-15
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
62432
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1983-02-15
Regulatory Status
Discontinued
Drug Name
DURACLON
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
1996-10-02
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
20615
Product Number
1
Dosage Form
-
Strength
1MG/10ML (0.1MG/ML)
Approval Date
1996-10-02
Regulatory Status
RX
Drug Name
DURACLON
Product Number
2
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-04-27
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
20615
Product Number
2
Dosage Form
-
Strength
5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1999-04-27
Regulatory Status
Discontinued
Drug Name
DYMISTA
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY;0.05MG/SPRAY
Approval Date
2012-05-01
Active Ingredient
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Application Number
202236
Product Number
1
Dosage Form
-
Strength
0.137MG/SPRAY;0.05MG/SPRAY
Approval Date
2012-05-01
Regulatory Status
RX
Drug Name
EDLUAR
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2009-03-13
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
21997
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2009-03-13
Regulatory Status
RX
Drug Name
EDLUAR
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-03-13
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
21997
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-03-13
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
EFAVIRENZ
Application Number
22461
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
EFAVIRENZ
Application Number
22461
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
EFAVIRENZ
Application Number
22461
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2016-02-17
Active Ingredient
EFAVIRENZ
Application Number
91471
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2016-02-17
Regulatory Status
Discontinued
Drug Name
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Product Number
1
Dosage Form
-
Strength
400MG; 200MG; 25MG
Approval Date
-
Active Ingredient
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Application Number
213509
Product Number
1
Dosage Form
-
Strength
400MG; 200MG; 25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG; 200MG; 300MG
Approval Date
-
Active Ingredient
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
90437
Product Number
1
Dosage Form
-
Strength
600MG; 200MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG;200MG;300MG
Approval Date
2024-09-05
Active Ingredient
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
209061
Product Number
1
Dosage Form
-
Strength
600MG;200MG;300MG
Approval Date
2024-09-05
Regulatory Status
Discontinued
Drug Name
ELESTRIN
Product Number
1
Dosage Form
-
Strength
0.06% (0.87GM/ACTIVATION)
Approval Date
2006-12-15
Active Ingredient
ESTRADIOL
Application Number
21813
Product Number
1
Dosage Form
-
Strength
0.06% (0.87GM/ACTIVATION)
Approval Date
2006-12-15
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-08-11
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
205152
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-08-11
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-08-11
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
205152
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-08-11
Regulatory Status
RX
Drug Name
EMTRICITABINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
EMTRICITABINE
Application Number
90488
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG;EQ 25MG BASE;300MG
Approval Date
2025-05-20
Active Ingredient
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
208452
Product Number
1
Dosage Form
-
Strength
200MG;EQ 25MG BASE;300MG
Approval Date
2025-05-20
Regulatory Status
RX
Drug Name
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG; 300MG
Approval Date
-
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
90049
Product Number
1
Dosage Form
-
Strength
200MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ENALAPRIL MALEATE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2000-08-22
Active Ingredient
ENALAPRIL MALEATE
Application Number
75472
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2000-08-22
Regulatory Status
Discontinued
Drug Name
ENALAPRIL MALEATE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2000-08-22
Active Ingredient
ENALAPRIL MALEATE
Application Number
75472
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2000-08-22
Regulatory Status
Discontinued
Drug Name
ENALAPRIL MALEATE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2000-08-22
Active Ingredient
ENALAPRIL MALEATE
Application Number
75472
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2000-08-22
Regulatory Status
Discontinued
Drug Name
ENALAPRIL MALEATE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2000-08-22
Active Ingredient
ENALAPRIL MALEATE
Application Number
75472
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2000-08-22
Regulatory Status
Discontinued
Drug Name
EPI E Z PEN JR
Product Number
4
Dosage Form
-
Strength
0.15MG/DELIVERY
Approval Date
1995-08-03
Active Ingredient
EPINEPHRINE
Application Number
19430
Product Number
4
Dosage Form
-
Strength
0.15MG/DELIVERY
Approval Date
1995-08-03
Regulatory Status
Discontinued
Drug Name
EPIFOAM
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Application Number
86457
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
EPIPEN
Product Number
1
Dosage Form
-
Strength
0.3MG/DELIVERY
Approval Date
1987-12-22
Active Ingredient
EPINEPHRINE
Application Number
19430
Product Number
1
Dosage Form
-
Strength
0.3MG/DELIVERY
Approval Date
1987-12-22
Regulatory Status
RX
Drug Name
EPIPEN E Z PEN
Product Number
3
Dosage Form
-
Strength
0.3MG/DELIVERY
Approval Date
1995-08-03
Active Ingredient
EPINEPHRINE
Application Number
19430
Product Number
3
Dosage Form
-
Strength
0.3MG/DELIVERY
Approval Date
1995-08-03
Regulatory Status
Discontinued
Drug Name
EPIPEN JR.
Product Number
2
Dosage Form
-
Strength
0.15MG/DELIVERY
Approval Date
1987-12-22
Active Ingredient
EPINEPHRINE
Application Number
19430
Product Number
2
Dosage Form
-
Strength
0.15MG/DELIVERY
Approval Date
1987-12-22
Regulatory Status
RX
Drug Name
EPOPROSTENOL SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/VIAL
Approval Date
2024-06-12
Active Ingredient
EPOPROSTENOL SODIUM
Application Number
213913
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE/VIAL
Approval Date
2024-06-12
Regulatory Status
RX
Drug Name
EPOPROSTENOL SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1.5MG BASE/VIAL
Approval Date
2024-06-12
Active Ingredient
EPOPROSTENOL SODIUM
Application Number
213913
Product Number
2
Dosage Form
-
Strength
EQ 1.5MG BASE/VIAL
Approval Date
2024-06-12
Regulatory Status
RX
Drug Name
EPTIFIBATIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2018-07-20
Active Ingredient
EPTIFIBATIDE
Application Number
203258
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2018-07-20
Regulatory Status
RX
Drug Name
EPTIFIBATIDE
Product Number
2
Dosage Form
-
Strength
75MG/100ML
Approval Date
2018-07-20
Active Ingredient
EPTIFIBATIDE
Application Number
203258
Product Number
2
Dosage Form
-
Strength
75MG/100ML
Approval Date
2018-07-20
Regulatory Status
RX
Drug Name
EPZICOM
Product Number
1
Dosage Form
-
Strength
600MG;300MG
Approval Date
-
Active Ingredient
ABACAVIR;LAMIVUDINE
Application Number
204004
Product Number
1
Dosage Form
-
Strength
600MG;300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ERMEZA
Product Number
1
Dosage Form
-
Strength
150MCG/5ML
Approval Date
2022-04-29
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
215809
Product Number
1
Dosage Form
-
Strength
150MCG/5ML
Approval Date
2022-04-29
Regulatory Status
RX
Drug Name
ERYGEL
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1987-10-21
Active Ingredient
ERYTHROMYCIN
Application Number
50617
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1987-10-21
Regulatory Status
Discontinued
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2005-05-02
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
76474
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2005-05-02
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2018-06-08
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
206608
Product Number
1
Dosage Form
-
Strength
1GM/100ML
Approval Date
2018-06-08
Regulatory Status
RX
Drug Name
ESMOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2018-06-08
Active Ingredient
ESMOLOL HYDROCHLORIDE
Application Number
206608
Product Number
2
Dosage Form
-
Strength
2GM/100ML
Approval Date
2018-06-08
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-08-02
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
78936
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2015-08-02
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2015-08-03
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
78936
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2015-08-03
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-06-25
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
212088
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-06-25
Regulatory Status
Discontinued
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
1
Dosage Form
-
Strength
0.025MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.0375MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
2
Dosage Form
-
Strength
0.0375MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
3
Dosage Form
-
Strength
0.05MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.075MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
4
Dosage Form
-
Strength
0.075MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.1MG/DAY
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
20167
Product Number
5
Dosage Form
-
Strength
0.1MG/DAY
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2000-02-24
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
1
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2000-02-24
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2005-01-26
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2005-01-26
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2005-01-26
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
3
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2005-01-26
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2006-07-20
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
4
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2006-07-20
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.06MG/24HR
Approval Date
2006-07-20
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
5
Dosage Form
-
Strength
0.06MG/24HR
Approval Date
2006-07-20
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
6
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2000-02-24
Active Ingredient
ESTRADIOL
Application Number
75182
Product Number
6
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2000-02-24
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
-
Active Ingredient
ESTRADIOL
Application Number
75233
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2014-12-19
Active Ingredient
ESTRADIOL
Application Number
201675
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2014-12-19
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
1
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
2
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
4
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2018-08-15
Active Ingredient
ESTRADIOL
Application Number
206685
Product Number
5
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2018-08-15
Regulatory Status
RX
Drug Name
ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2017-12-29
Active Ingredient
ESTRADIOL
Application Number
208788
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2017-12-29
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-03-26
Active Ingredient
ESZOPICLONE
Application Number
91151
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2013-03-26
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2013-03-26
Active Ingredient
ESZOPICLONE
Application Number
91151
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2013-03-26
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2013-03-26
Active Ingredient
ESZOPICLONE
Application Number
91151
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2013-03-26
Regulatory Status
RX
Drug Name
ETHACRYNATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2016-08-23
Active Ingredient
ETHACRYNATE SODIUM
Application Number
204634
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2016-08-23
Regulatory Status
Discontinued
Drug Name
ETODOLAC
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1998-09-30
Active Ingredient
ETODOLAC
Application Number
75012
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1998-09-30
Regulatory Status
Discontinued
Drug Name
ETODOLAC
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1998-09-30
Active Ingredient
ETODOLAC
Application Number
75012
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
1998-09-30
Regulatory Status
Discontinued
Drug Name
ETODOLAC
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1998-09-30
Active Ingredient
ETODOLAC
Application Number
75071
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1998-09-30
Regulatory Status
Discontinued
Drug Name
ETODOLAC
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1998-09-30
Active Ingredient
ETODOLAC
Application Number
75071
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1998-09-30
Regulatory Status
Discontinued
Drug Name
ETOMIDATE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-02-07
Active Ingredient
ETOMIDATE
Application Number
201044
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2017-02-07
Regulatory Status
RX
Drug Name
ETOPOSIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2001-09-19
Active Ingredient
ETOPOSIDE
Application Number
75635
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2001-09-19
Regulatory Status
RX
Drug Name
EVEROLIMUS
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2019-04-19
Active Ingredient
EVEROLIMUS
Application Number
210130
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2019-04-19
Regulatory Status
Discontinued
Drug Name
EVEROLIMUS
Product Number
2
Dosage Form
-
Strength
3MG
Approval Date
2019-04-19
Active Ingredient
EVEROLIMUS
Application Number
210130
Product Number
2
Dosage Form
-
Strength
3MG
Approval Date
2019-04-19
Regulatory Status
Discontinued
Drug Name
EVEROLIMUS
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2019-04-19
Active Ingredient
EVEROLIMUS
Application Number
210130
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2019-04-19
Regulatory Status
Discontinued
Drug Name
EVEROLIMUS
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
212936
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-06-08
Regulatory Status
Discontinued
Drug Name
EVEROLIMUS
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
212936
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-06-08
Regulatory Status
Discontinued
Drug Name
EVEROLIMUS
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
212936
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2020-06-08
Regulatory Status
Discontinued
Drug Name
EVEROLIMUS
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2020-06-08
Active Ingredient
EVEROLIMUS
Application Number
212936
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2020-06-08
Regulatory Status
Discontinued
Drug Name
EXTENDED PHENYTOIN SODIUM
Product Number
1
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
1998-12-28
Active Ingredient
PHENYTOIN SODIUM
Application Number
40298
Product Number
1
Dosage Form
-
Strength
100MG EXTENDED
Approval Date
1998-12-28
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-04-18
Active Ingredient
FAMOTIDINE
Application Number
75457
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-04-18
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-04-18
Active Ingredient
FAMOTIDINE
Application Number
75457
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-04-18
Regulatory Status
Discontinued
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Active Ingredient
FAMOTIDINE
Application Number
78641
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Regulatory Status
RX
Drug Name
FAMOTIDINE PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Active Ingredient
FAMOTIDINE
Application Number
78642
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2008-06-25
Regulatory Status
RX
Drug Name
FELBATOL
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1993-07-29
Active Ingredient
FELBAMATE
Application Number
20189
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1993-07-29
Regulatory Status
RX
Drug Name
FELBATOL
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
1993-07-29
Active Ingredient
FELBAMATE
Application Number
20189
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
1993-07-29
Regulatory Status
RX
Drug Name
FELBATOL
Product Number
3
Dosage Form
-
Strength
600MG/5ML
Approval Date
1993-07-29
Active Ingredient
FELBAMATE
Application Number
20189
Product Number
3
Dosage Form
-
Strength
600MG/5ML
Approval Date
1993-07-29
Regulatory Status
Discontinued
Drug Name
FELODIPINE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2008-04-17
Active Ingredient
FELODIPINE
Application Number
78855
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2008-04-17
Regulatory Status
Discontinued
Drug Name
FELODIPINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2008-04-17
Active Ingredient
FELODIPINE
Application Number
78855
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2008-04-17
Regulatory Status
Discontinued
Drug Name
FELODIPINE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2008-04-17
Active Ingredient
FELODIPINE
Application Number
78855
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2008-04-17
Regulatory Status
Discontinued
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2007-10-25
Active Ingredient
FENOFIBRATE
Application Number
76520
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2007-10-25
Regulatory Status
Discontinued
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
107MG
Approval Date
2005-12-29
Active Ingredient
FENOFIBRATE
Application Number
76520
Product Number
2
Dosage Form
-
Strength
107MG
Approval Date
2005-12-29
Regulatory Status
Discontinued
Drug Name
FENOFIBRATE
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2007-10-25
Active Ingredient
FENOFIBRATE
Application Number
76520
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2007-10-25
Regulatory Status
Discontinued
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2012-12-07
Active Ingredient
FENOFIBRATE
Application Number
202856
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2012-12-07
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2012-12-07
Active Ingredient
FENOFIBRATE
Application Number
202856
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2012-12-07
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2016-06-23
Active Ingredient
FENOFIBRATE
Application Number
204475
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2016-06-23
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2016-06-23
Active Ingredient
FENOFIBRATE
Application Number
204475
Product Number
2
Dosage Form
-
Strength
120MG
Approval Date
2016-06-23
Regulatory Status
RX
Drug Name
FENTANYL
Product Number
1
Dosage Form
-
Strength
100MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
1
Dosage Form
-
Strength
100MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
2
Dosage Form
-
Strength
200MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
2
Dosage Form
-
Strength
200MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
3
Dosage Form
-
Strength
300MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
3
Dosage Form
-
Strength
300MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
4
Dosage Form
-
Strength
400MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
4
Dosage Form
-
Strength
400MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
5
Dosage Form
-
Strength
600MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
5
Dosage Form
-
Strength
600MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL
Product Number
6
Dosage Form
-
Strength
800MCG
Approval Date
-
Active Ingredient
FENTANYL
Application Number
202577
Product Number
6
Dosage Form
-
Strength
800MCG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FENTANYL-100
Product Number
4
Dosage Form
-
Strength
100MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
4
Dosage Form
-
Strength
100MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-12
Product Number
5
Dosage Form
-
Strength
12.5MCG/HR
Approval Date
2007-01-23
Active Ingredient
FENTANYL
Application Number
76258
Product Number
5
Dosage Form
-
Strength
12.5MCG/HR
Approval Date
2007-01-23
Regulatory Status
RX
Drug Name
FENTANYL-25
Product Number
1
Dosage Form
-
Strength
25MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
1
Dosage Form
-
Strength
25MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-37
Product Number
6
Dosage Form
-
Strength
37.5MCG/HR
Approval Date
2014-12-29
Active Ingredient
FENTANYL
Application Number
76258
Product Number
6
Dosage Form
-
Strength
37.5MCG/HR
Approval Date
2014-12-29
Regulatory Status
RX
Drug Name
FENTANYL-50
Product Number
2
Dosage Form
-
Strength
50MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
2
Dosage Form
-
Strength
50MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-62
Product Number
7
Dosage Form
-
Strength
62.5MCG/HR
Approval Date
2014-12-29
Active Ingredient
FENTANYL
Application Number
76258
Product Number
7
Dosage Form
-
Strength
62.5MCG/HR
Approval Date
2014-12-29
Regulatory Status
RX
Drug Name
FENTANYL-75
Product Number
3
Dosage Form
-
Strength
75MCG/HR
Approval Date
2005-01-28
Active Ingredient
FENTANYL
Application Number
76258
Product Number
3
Dosage Form
-
Strength
75MCG/HR
Approval Date
2005-01-28
Regulatory Status
RX
Drug Name
FENTANYL-87
Product Number
8
Dosage Form
-
Strength
87.5MCG/HR
Approval Date
2014-12-29
Active Ingredient
FENTANYL
Application Number
76258
Product Number
8
Dosage Form
-
Strength
87.5MCG/HR
Approval Date
2014-12-29
Regulatory Status
RX
Drug Name
FERRIC CARBOXYMALTOSE
Product Number
1
Dosage Form
-
Strength
750MG IRON/15ML (50MG IRON/ML)
Approval Date
2026-06-25
Active Ingredient
FERRIC CARBOXYMALTOSE
Application Number
212572
Product Number
1
Dosage Form
-
Strength
750MG IRON/15ML (50MG IRON/ML)
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
FERRIC CARBOXYMALTOSE
Product Number
1
Dosage Form
-
Strength
1GM IRON/20ML (50MG IRON/ML)
Approval Date
2026-06-25
Active Ingredient
FERRIC CARBOXYMALTOSE
Application Number
217076
Product Number
1
Dosage Form
-
Strength
1GM IRON/20ML (50MG IRON/ML)
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
FERRIC CARBOXYMALTOSE
Product Number
1
Dosage Form
-
Strength
100MG IRON/2ML (50MG IRON/ML)
Approval Date
2026-06-25
Active Ingredient
FERRIC CARBOXYMALTOSE
Application Number
217769
Product Number
1
Dosage Form
-
Strength
100MG IRON/2ML (50MG IRON/ML)
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
Product Number
1
Dosage Form
-
Strength
60/120MG
Approval Date
-
Active Ingredient
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
76538
Product Number
1
Dosage Form
-
Strength
60/120MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
FINASTERIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2006-12-18
Active Ingredient
FINASTERIDE
Application Number
77578
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2006-12-18
Regulatory Status
Discontinued
Drug Name
FINGOLIMOD HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2021-01-19
Active Ingredient
FINGOLIMOD HYDROCHLORIDE
Application Number
208005
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2021-01-19
Regulatory Status
Discontinued
Drug Name
FLUCONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2004-07-29
Active Ingredient
FLUCONAZOLE
Application Number
76042
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2004-07-29
Regulatory Status
Discontinued
Drug Name
FLUCONAZOLE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2004-07-29
Active Ingredient
FLUCONAZOLE
Application Number
76042
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2004-07-29
Regulatory Status
Discontinued
Drug Name
FLUCONAZOLE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2004-07-29
Active Ingredient
FLUCONAZOLE
Application Number
76042
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2004-07-29
Regulatory Status
Discontinued
Drug Name
FLUCONAZOLE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2004-07-29
Active Ingredient
FLUCONAZOLE
Application Number
76042
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2004-07-29
Regulatory Status
Discontinued
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2005-03-25
Active Ingredient
FLUCONAZOLE
Application Number
76889
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2005-03-25
Regulatory Status
Discontinued
Drug Name
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2005-03-25
Active Ingredient
FLUCONAZOLE
Application Number
76889
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2005-03-25
Regulatory Status
Discontinued
Drug Name
FLUPHENAZINE DECANOATE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2001-08-17
Active Ingredient
FLUPHENAZINE DECANOATE
Application Number
75918
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2001-08-17
Regulatory Status
RX
Drug Name
FLUVASTATIN SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-04-11
Active Ingredient
FLUVASTATIN SODIUM
Application Number
90595
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-04-11
Regulatory Status
RX
Drug Name
FLUVASTATIN SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-04-11
Active Ingredient
FLUVASTATIN SODIUM
Application Number
90595
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-04-11
Regulatory Status
RX
Drug Name
FLUVOXAMINE MALEATE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2001-10-15
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
75950
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2001-10-15
Regulatory Status
Discontinued
Drug Name
FLUVOXAMINE MALEATE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2001-10-15
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
75950
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2001-10-15
Regulatory Status
Discontinued
Drug Name
FOMEPIZOLE
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2008-03-03
Active Ingredient
FOMEPIZOLE
Application Number
78639
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2008-03-03
Regulatory Status
RX
Drug Name
FOMEPIZOLE
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2009-04-07
Active Ingredient
FOMEPIZOLE
Application Number
79033
Product Number
1
Dosage Form
-
Strength
1.5GM/1.5ML (1GM/ML)
Approval Date
2009-04-07
Regulatory Status
Discontinued
Drug Name
FOSAMPRENAVIR CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 700MG BASE
Approval Date
2016-04-15
Active Ingredient
FOSAMPRENAVIR CALCIUM
Application Number
204060
Product Number
1
Dosage Form
-
Strength
EQ 700MG BASE
Approval Date
2016-04-15
Regulatory Status
RX
Drug Name
FOSAPREPITANT DIMEGLUMINE
Product Number
1
Dosage Form
-
Strength
EQ 115MG BASE/VIAL
Approval Date
2019-09-05
Active Ingredient
FOSAPREPITANT DIMEGLUMINE
Application Number
204015
Product Number
1
Dosage Form
-
Strength
EQ 115MG BASE/VIAL
Approval Date
2019-09-05
Regulatory Status
Discontinued
Drug Name
FOSAPREPITANT DIMEGLUMINE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2019-09-05
Active Ingredient
FOSAPREPITANT DIMEGLUMINE
Application Number
204015
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2019-09-05
Regulatory Status
RX
Drug Name
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2006-08-14
Active Ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Application Number
77705
Product Number
1
Dosage Form
-
Strength
10MG;12.5MG
Approval Date
2006-08-14
Regulatory Status
Discontinued
Drug Name
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2006-08-14
Active Ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Application Number
77705
Product Number
2
Dosage Form
-
Strength
20MG;12.5MG
Approval Date
2006-08-14
Regulatory Status
Discontinued
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2009-05-29
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
77590
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2009-05-29
Regulatory Status
Discontinued
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2009-05-29
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
77590
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2009-05-29
Regulatory Status
Discontinued
Drug Name
GALANTAMINE HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2009-05-29
Active Ingredient
GALANTAMINE HYDROBROMIDE
Application Number
77590
Product Number
3
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2009-05-29
Regulatory Status
Discontinued
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/5.26ML (38MG/ML)
Approval Date
2017-12-06
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
205242
Product Number
1
Dosage Form
-
Strength
200MG/5.26ML (38MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/26.3ML (38MG/ML)
Approval Date
2017-12-06
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
205242
Product Number
2
Dosage Form
-
Strength
1GM/26.3ML (38MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
GEMCITABINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2GM/52.6ML (38MG/ML)
Approval Date
2017-12-06
Active Ingredient
GEMCITABINE HYDROCHLORIDE
Application Number
205242
Product Number
3
Dosage Form
-
Strength
2GM/52.6ML (38MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
GEODON
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2001-02-05
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
20825
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2001-02-05
Regulatory Status
RX
Drug Name
GEODON
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2002-06-21
Active Ingredient
ZIPRASIDONE MESYLATE
Application Number
20919
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2002-06-21
Regulatory Status
RX
Drug Name
GLATIRAMER ACETATE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2017-10-03
Active Ingredient
GLATIRAMER ACETATE
Application Number
91646
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
GLATIRAMER ACETATE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2017-10-03
Active Ingredient
GLATIRAMER ACETATE
Application Number
206936
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2006-02-10
Active Ingredient
GLIMEPIRIDE
Application Number
77486
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2006-02-10
Regulatory Status
Discontinued
Drug Name
GLIMEPIRIDE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2006-02-10
Active Ingredient
GLIMEPIRIDE
Application Number
77486
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2006-02-10
Regulatory Status
Discontinued
Drug Name
GLIMEPIRIDE
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2006-02-10
Active Ingredient
GLIMEPIRIDE
Application Number
77486
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2006-02-10
Regulatory Status
Discontinued
Drug Name
GLUCAGON
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2024-12-12
Active Ingredient
GLUCAGON
Application Number
204468
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2024-12-12
Regulatory Status
RX
Drug Name
HALCINONIDE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2019-08-12
Active Ingredient
HALCINONIDE
Application Number
211027
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2019-08-12
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-07-16
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2009-07-16
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2009-07-16
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2009-07-16
Regulatory Status
Discontinued
Drug Name
HALOPERIDOL
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
6
Dosage Form
-
Strength
0.5MG
Approval Date
1986-06-10
Active Ingredient
HALOPERIDOL
Application Number
70278
Product Number
6
Dosage Form
-
Strength
0.5MG
Approval Date
1986-06-10
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2009-09-14
Active Ingredient
HALOPERIDOL LACTATE
Application Number
78347
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2009-09-14
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2000-02-28
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
75440
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2000-02-28
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2000-02-28
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
75440
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2000-02-28
Regulatory Status
RX
Drug Name
HULIO
Product Number
1
Dosage Form
-
Strength
20MG;0.4ML
Approval Date
-
Active Ingredient
ADALIMUMAB-FKJP
Application Number
761154
Product Number
1
Dosage Form
-
Strength
20MG;0.4ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE
Product Number
1
Dosage Form
-
Strength
25MG;15MG;0.1MG
Approval Date
1982-01-01
Active Ingredient
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
Application Number
87085
Product Number
1
Dosage Form
-
Strength
25MG;15MG;0.1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
84880
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
85112
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYZYD
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Active Ingredient
ISONIAZID
Application Number
80134
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
HYZYD
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
ISONIAZID
Application Number
80134
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
IBUTILIDE FUMARATE
Product Number
1
Dosage Form
-
Strength
0.1MG/ML
Approval Date
2010-01-11
Active Ingredient
IBUTILIDE FUMARATE
Application Number
90924
Product Number
1
Dosage Form
-
Strength
0.1MG/ML
Approval Date
2010-01-11
Regulatory Status
Discontinued
Drug Name
IMATINIB MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-06-21
Active Ingredient
IMATINIB MESYLATE
Application Number
204644
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-06-21
Regulatory Status
RX
Drug Name
IMATINIB MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-06-21
Active Ingredient
IMATINIB MESYLATE
Application Number
204644
Product Number
2
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-06-21
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2014-03-20
Active Ingredient
INDOMETHACIN
Application Number
202139
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2014-03-20
Regulatory Status
Discontinued
Drug Name
IRON SUCROSE
Product Number
1
Dosage Form
-
Strength
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212559
Product Number
1
Dosage Form
-
Strength
EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
2
Dosage Form
-
Strength
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212559
Product Number
2
Dosage Form
-
Strength
EQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
IRON SUCROSE
Product Number
3
Dosage Form
-
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Active Ingredient
IRON SUCROSE
Application Number
212559
Product Number
3
Dosage Form
-
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2010-07-20
Active Ingredient
ISOSULFAN BLUE
Application Number
90874
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2010-07-20
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
2
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2026-01-28
Active Ingredient
ISOSULFAN BLUE
Application Number
90874
Product Number
2
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2026-01-28
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
3
Dosage Form
-
Strength
30MG/3ML (10MG/ML)
Approval Date
2026-01-28
Active Ingredient
ISOSULFAN BLUE
Application Number
90874
Product Number
3
Dosage Form
-
Strength
30MG/3ML (10MG/ML)
Approval Date
2026-01-28
Regulatory Status
RX
Drug Name
ITRACONAZOLE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-07-20
Active Ingredient
ITRACONAZOLE
Application Number
200463
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-07-20
Regulatory Status
Discontinued
Drug Name
KETOPROFEN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2002-02-20
Active Ingredient
KETOPROFEN
Application Number
75679
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2002-02-20
Regulatory Status
RX
Drug Name
KETOPROFEN
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2002-02-20
Active Ingredient
KETOPROFEN
Application Number
75679
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2002-02-20
Regulatory Status
Discontinued
Drug Name
KETOPROFEN
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2002-02-20
Active Ingredient
KETOPROFEN
Application Number
75679
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2002-02-20
Regulatory Status
Discontinued
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1997-05-16
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
74761
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1997-05-16
Regulatory Status
RX
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
202171
Product Number
1
Dosage Form
-
Strength
300MG; 300MG; 200MG
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
200748
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
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
204914
Product Number
1
Dosage Form
-
Strength
30MG; 60MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2009-11-10
Active Ingredient
LANSOPRAZOLE
Application Number
90763
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2009-11-10
Active Ingredient
LANSOPRAZOLE
Application Number
90763
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2009-11-10
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2018-11-28
Active Ingredient
LANSOPRAZOLE
Application Number
202396
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2018-11-28
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2018-11-28
Active Ingredient
LANSOPRAZOLE
Application Number
202396
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2018-11-28
Regulatory Status
RX
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2016-06-01
Active Ingredient
LANSOPRAZOLE
Application Number
203187
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2016-06-01
Regulatory Status
Discontinued
Drug Name
LENALIDOMIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2022-08-30
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
4
Dosage Form
-
Strength
25MG
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2023-03-06
Active Ingredient
LENALIDOMIDE
Application Number
213912
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2017-05-19
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
203800
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2017-05-19
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
2017-05-19
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
203800
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE/VIAL
Approval Date
2017-05-19
Regulatory Status
RX
Drug Name
LEUCOVORIN CALCIUM PRESERVATIVE FREE
Product Number
3
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2017-05-19
Active Ingredient
LEUCOVORIN CALCIUM
Application Number
203800
Product Number
3
Dosage Form
-
Strength
EQ 350MG BASE/VIAL
Approval Date
2017-05-19
Regulatory Status
RX
Drug Name
LEVALBUTEROL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2009-03-20
Active Ingredient
LEVALBUTEROL HYDROCHLORIDE
Application Number
78309
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2009-03-20
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2008-11-04
Active Ingredient
LEVETIRACETAM
Application Number
76919
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2008-11-04
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2008-11-04
Active Ingredient
LEVETIRACETAM
Application Number
76919
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2008-11-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2008-11-04
Active Ingredient
LEVETIRACETAM
Application Number
76919
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2008-11-04
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-02-10
Active Ingredient
LEVETIRACETAM
Application Number
78731
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-02-10
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-02-10
Active Ingredient
LEVETIRACETAM
Application Number
78731
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-02-10
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2009-02-10
Active Ingredient
LEVETIRACETAM
Application Number
78731
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2009-02-10
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2009-02-10
Active Ingredient
LEVETIRACETAM
Application Number
78731
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2009-02-10
Regulatory Status
Discontinued
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2009-12-08
Active Ingredient
LEVETIRACETAM
Application Number
90261
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2009-12-08
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2016-09-16
Active Ingredient
LEVETIRACETAM
Application Number
203308
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2026-05-08
Active Ingredient
LEVETIRACETAM
Application Number
218364
Product Number
1
Dosage Form
-
Strength
500MG/100ML (5MG/ML)
Approval Date
2026-05-08
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2026-05-08
Active Ingredient
LEVETIRACETAM
Application Number
218364
Product Number
2
Dosage Form
-
Strength
1GM/100ML (10MG/ML)
Approval Date
2026-05-08
Regulatory Status
RX
Drug Name
LEVETIRACETAM IN SODIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2026-05-08
Active Ingredient
LEVETIRACETAM
Application Number
218364
Product Number
3
Dosage Form
-
Strength
1.5GM/100ML (15MG/ML)
Approval Date
2026-05-08
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
8
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
8
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
9
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
9
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
10
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
10
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
11
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
11
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2002-06-05
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
12
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2006-12-13
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76187
Product Number
12
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2006-12-13
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
1
Dosage Form
-
Strength
0.025MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
1
Dosage Form
-
Strength
0.025MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
2
Dosage Form
-
Strength
0.050MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
2
Dosage Form
-
Strength
0.050MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
3
Dosage Form
-
Strength
0.075MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
3
Dosage Form
-
Strength
0.075MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
4
Dosage Form
-
Strength
0.088MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
4
Dosage Form
-
Strength
0.088MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
5
Dosage Form
-
Strength
0.1MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
5
Dosage Form
-
Strength
0.1MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
6
Dosage Form
-
Strength
0.112MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
6
Dosage Form
-
Strength
0.112MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
7
Dosage Form
-
Strength
0.125MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
7
Dosage Form
-
Strength
0.125MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
8
Dosage Form
-
Strength
0.15MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
8
Dosage Form
-
Strength
0.15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
9
Dosage Form
-
Strength
0.175MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
9
Dosage Form
-
Strength
0.175MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
10
Dosage Form
-
Strength
0.2MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
10
Dosage Form
-
Strength
0.2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEVOTHYROXINE SODIUM
Product Number
11
Dosage Form
-
Strength
0.3MG
Approval Date
-
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
76764
Product Number
11
Dosage Form
-
Strength
0.3MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LINACLOTIDE
Product Number
1
Dosage Form
-
Strength
145MCG
Approval Date
2021-02-09
Active Ingredient
LINACLOTIDE
Application Number
209564
Product Number
1
Dosage Form
-
Strength
145MCG
Approval Date
2021-02-09
Regulatory Status
Discontinued
Drug Name
LINACLOTIDE
Product Number
2
Dosage Form
-
Strength
290MCG
Approval Date
2021-02-09
Active Ingredient
LINACLOTIDE
Application Number
209564
Product Number
2
Dosage Form
-
Strength
290MCG
Approval Date
2021-02-09
Regulatory Status
Discontinued
Drug Name
LINAGLIPTIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN
Application Number
208431
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
-
Active Ingredient
LINAGLIPTIN;METFORMIN HYDROCHLORIDE
Application Number
208430
Product Number
1
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG;850MG
Approval Date
-
Active Ingredient
LINAGLIPTIN;METFORMIN HYDROCHLORIDE
Application Number
208430
Product Number
2
Dosage Form
-
Strength
2.5MG;850MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2.5MG;1GM
Approval Date
-
Active Ingredient
LINAGLIPTIN;METFORMIN HYDROCHLORIDE
Application Number
208430
Product Number
3
Dosage Form
-
Strength
2.5MG;1GM
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LIRAGLUTIDE
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2026-06-15
Active Ingredient
LIRAGLUTIDE
Application Number
213155
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2026-06-15
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
7
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
202835
Product Number
7
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LOPERAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1991-09-18
Active Ingredient
LOPERAMIDE HYDROCHLORIDE
Application Number
72741
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1991-09-18
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2024-02-07
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
79074
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2024-02-07
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
79074
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
LORATADINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2003-08-20
Active Ingredient
LORATADINE
Application Number
76154
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2003-08-20
Regulatory Status
OTC
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
91590
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
91590
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
91590
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
91652
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
12.5MG;100MG
Approval Date
2010-04-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91652
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-04-06
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-10-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91652
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-10-06
Regulatory Status
Discontinued
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-12-03
Active Ingredient
MACITENTAN
Application Number
211161
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-12-03
Regulatory Status
RX
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
2GM/50ML (40MG/ML)
Approval Date
2018-09-14
Active Ingredient
MAGNESIUM SULFATE
Application Number
209911
Product Number
1
Dosage Form
-
Strength
2GM/50ML (40MG/ML)
Approval Date
2018-09-14
Regulatory Status
Discontinued
Drug Name
MAGNESIUM SULFATE IN PLASTIC CONTAINER
Product Number
2
Dosage Form
-
Strength
4GM/100ML (40MG/ML)
Approval Date
2018-09-14
Active Ingredient
MAGNESIUM SULFATE
Application Number
209911
Product Number
2
Dosage Form
-
Strength
4GM/100ML (40MG/ML)
Approval Date
2018-09-14
Regulatory Status
Discontinued
Drug Name
MECLOFENAMATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-09-03
Active Ingredient
MECLOFENAMATE SODIUM
Application Number
71081
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1986-09-03
Regulatory Status
RX
Drug Name
MECLOFENAMATE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-09-03
Active Ingredient
MECLOFENAMATE SODIUM
Application Number
71081
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1986-09-03
Regulatory Status
RX
Drug Name
MELOXICAM
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2006-07-20
Active Ingredient
MELOXICAM
Application Number
77934
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2006-07-20
Regulatory Status
Discontinued
Drug Name
MELOXICAM
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2006-07-20
Active Ingredient
MELOXICAM
Application Number
77934
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2006-07-20
Regulatory Status
Discontinued
Drug Name
MELPHALAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2009-06-09
Active Ingredient
MELPHALAN HYDROCHLORIDE
Application Number
90270
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2009-06-09
Regulatory Status
RX
Drug Name
MELPHALAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2009-10-27
Active Ingredient
MELPHALAN HYDROCHLORIDE
Application Number
90299
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/VIAL
Approval Date
2009-10-27
Regulatory Status
Discontinued
Drug Name
MEPROBAMATE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
83618
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPROSPAN
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
11284
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MEPROSPAN
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
11284
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MERCAPTOPURINE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2005-07-01
Active Ingredient
MERCAPTOPURINE
Application Number
40594
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2005-07-01
Regulatory Status
Discontinued
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
1.2GM
Approval Date
2018-11-20
Active Ingredient
MESALAMINE
Application Number
203574
Product Number
1
Dosage Form
-
Strength
1.2GM
Approval Date
2018-11-20
Regulatory Status
Discontinued
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2019-11-20
Active Ingredient
MESALAMINE
Application Number
207271
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
MESNA
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2012-03-08
Active Ingredient
MESNA
Application Number
76488
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2012-03-08
Regulatory Status
Discontinued
Drug Name
METAPROTERENOL SULFATE
Product Number
1
Dosage Form
-
Strength
0.6%
Approval Date
1987-08-17
Active Ingredient
METAPROTERENOL SULFATE
Application Number
70804
Product Number
1
Dosage Form
-
Strength
0.6%
Approval Date
1987-08-17
Regulatory Status
Discontinued
Drug Name
METAPROTERENOL SULFATE
Product Number
1
Dosage Form
-
Strength
0.4%
Approval Date
1988-08-05
Active Ingredient
METAPROTERENOL SULFATE
Application Number
71786
Product Number
1
Dosage Form
-
Strength
0.4%
Approval Date
1988-08-05
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75973
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2002-01-25
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75973
Product Number
2
Dosage Form
-
Strength
850MG
Approval Date
2002-01-25
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2002-01-25
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
75973
Product Number
3
Dosage Form
-
Strength
1GM
Approval Date
2002-01-25
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-08-01
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
200690
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2012-08-01
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2012-08-01
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
200690
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2012-08-01
Regulatory Status
RX
Drug Name
METHADONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1982-01-01
Active Ingredient
METHADONE HYDROCHLORIDE
Application Number
21624
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
METHIMAZOLE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2000-03-29
Active Ingredient
METHIMAZOLE
Application Number
40350
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2000-03-29
Regulatory Status
RX
Drug Name
METHIMAZOLE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2000-03-29
Active Ingredient
METHIMAZOLE
Application Number
40350
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2000-03-29
Regulatory Status
RX
Drug Name
METHIMAZOLE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2001-06-07
Active Ingredient
METHIMAZOLE
Application Number
40350
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2001-06-07
Regulatory Status
Discontinued
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
METHOCARBAMOL
Application Number
84259
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METHOCARBAMOL
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
1982-01-01
Active Ingredient
METHOCARBAMOL
Application Number
84323
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-05-15
Active Ingredient
METHOTREXATE SODIUM
Application Number
81235
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-05-15
Regulatory Status
RX
Drug Name
METHYCLOTHIAZIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-08-17
Active Ingredient
METHYCLOTHIAZIDE
Application Number
87671
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
1982-08-17
Regulatory Status
Discontinued
Drug Name
METHYLDOPA
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Active Ingredient
METHYLDOPA
Application Number
70075
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
METHYLNALTREXONE BROMIDE
Product Number
1
Dosage Form
-
Strength
12MG/0.6ML (12MG/0.6ML)
Approval Date
2025-05-28
Active Ingredient
METHYLNALTREXONE BROMIDE
Application Number
208592
Product Number
1
Dosage Form
-
Strength
12MG/0.6ML (12MG/0.6ML)
Approval Date
2025-05-28
Regulatory Status
Discontinued
Drug Name
METOLAZONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-12-23
Active Ingredient
METOLAZONE
Application Number
76698
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-12-23
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2004-10-19
Active Ingredient
METOLAZONE
Application Number
76698
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2004-10-19
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2004-10-19
Active Ingredient
METOLAZONE
Application Number
76698
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2004-10-19
Regulatory Status
RX
Drug Name
METOPROLOL SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG TARTRATE
Approval Date
2011-12-15
Active Ingredient
METOPROLOL SUCCINATE
Application Number
202033
Product Number
1
Dosage Form
-
Strength
EQ 25MG TARTRATE
Approval Date
2011-12-15
Regulatory Status
Discontinued
Drug Name
METOPROLOL SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG TARTRATE
Approval Date
2011-12-15
Active Ingredient
METOPROLOL SUCCINATE
Application Number
202033
Product Number
2
Dosage Form
-
Strength
EQ 50MG TARTRATE
Approval Date
2011-12-15
Regulatory Status
Discontinued
Drug Name
METOPROLOL SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG TARTRATE
Approval Date
2011-12-15
Active Ingredient
METOPROLOL SUCCINATE
Application Number
202033
Product Number
3
Dosage Form
-
Strength
EQ 100MG TARTRATE
Approval Date
2011-12-15
Regulatory Status
Discontinued
Drug Name
METOPROLOL SUCCINATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG TARTRATE
Approval Date
2011-12-15
Active Ingredient
METOPROLOL SUCCINATE
Application Number
202033
Product Number
4
Dosage Form
-
Strength
EQ 200MG TARTRATE
Approval Date
2011-12-15
Regulatory Status
Discontinued
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2004-01-16
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2004-01-16
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2004-01-16
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2004-01-16
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2004-01-16
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2004-01-16
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
4
Dosage Form
-
Strength
37.5MG
Approval Date
2015-03-18
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
4
Dosage Form
-
Strength
37.5MG
Approval Date
2015-03-18
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2015-03-18
Active Ingredient
METOPROLOL TARTRATE
Application Number
76704
Product Number
5
Dosage Form
-
Strength
75MG
Approval Date
2015-03-18
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;50MG
Approval Date
2004-08-20
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
76792
Product Number
1
Dosage Form
-
Strength
25MG;50MG
Approval Date
2004-08-20
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2004-08-20
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
76792
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2004-08-20
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
50MG;100MG
Approval Date
2004-08-20
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
76792
Product Number
3
Dosage Form
-
Strength
50MG;100MG
Approval Date
2004-08-20
Regulatory Status
RX
Drug Name
MICRAININ
Product Number
1
Dosage Form
-
Strength
325MG;200MG
Approval Date
1982-01-01
Active Ingredient
ASPIRIN; MEPROBAMATE
Application Number
84978
Product Number
1
Dosage Form
-
Strength
325MG;200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-09-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
76577
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2003-09-10
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2003-09-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
76577
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2003-09-10
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2003-09-10
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
76577
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2003-09-10
Regulatory Status
RX
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
205367
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILPREM-200
Product Number
2
Dosage Form
-
Strength
0.45MG;200MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, CONJUGATED; MEPROBAMATE
Application Number
11045
Product Number
2
Dosage Form
-
Strength
0.45MG;200MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MILPREM-400
Product Number
1
Dosage Form
-
Strength
0.45MG;400MG
Approval Date
1982-01-01
Active Ingredient
ESTROGENS, CONJUGATED; MEPROBAMATE
Application Number
11045
Product Number
1
Dosage Form
-
Strength
0.45MG;400MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MILRINONE LACTATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2003-06-16
Active Ingredient
MILRINONE LACTATE
Application Number
76428
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2003-06-16
Regulatory Status
Discontinued
Drug Name
MILTOWN
Product Number
2
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
9698
Product Number
2
Dosage Form
-
Strength
400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MILTOWN
Product Number
4
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
9698
Product Number
4
Dosage Form
-
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MILTOWN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1982-01-01
Active Ingredient
MEPROBAMATE
Application Number
83919
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
MIRTAZAPINE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2003-06-19
Active Ingredient
MIRTAZAPINE
Application Number
76122
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2003-06-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2003-06-19
Active Ingredient
MIRTAZAPINE
Application Number
76122
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2003-06-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2003-06-19
Active Ingredient
MIRTAZAPINE
Application Number
76122
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2003-06-19
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Product Number
1
Dosage Form
-
Strength
400MG/250ML (1.6MG/ML)
Approval Date
2017-05-05
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
205833
Product Number
1
Dosage Form
-
Strength
400MG/250ML (1.6MG/ML)
Approval Date
2017-05-05
Regulatory Status
RX
Drug Name
MUSE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
1996-11-19
Active Ingredient
ALPROSTADIL
Application Number
20700
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
1996-11-19
Regulatory Status
Discontinued
Drug Name
MUSE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1996-11-19
Active Ingredient
ALPROSTADIL
Application Number
20700
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
1996-11-19
Regulatory Status
Discontinued
Drug Name
MUSE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
1996-11-19
Active Ingredient
ALPROSTADIL
Application Number
20700
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
1996-11-19
Regulatory Status
Discontinued
Drug Name
MUSE
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1996-11-19
Active Ingredient
ALPROSTADIL
Application Number
20700
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
1996-11-19
Regulatory Status
Discontinued
Drug Name
MYCOLOG-II
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-06-28
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
60572
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1985-06-28
Regulatory Status
Discontinued
Drug Name
MYCOLOG-II
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Approval Date
1985-05-15
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
62606
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Approval Date
1985-05-15
Regulatory Status
Discontinued
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-05-04
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
65520
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-05-04
Regulatory Status
Discontinued
Drug Name
MYCOPHENOLATE MOFETIL
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2009-05-04
Active Ingredient
MYCOPHENOLATE MOFETIL
Application Number
65521
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2009-05-04
Regulatory Status
Discontinued
Drug Name
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-03-31
Active Ingredient
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Application Number
203859
Product Number
1
Dosage Form
-
Strength
500MG/VIAL
Approval Date
2017-03-31
Regulatory Status
RX
Drug Name
MYLAXEN
Product Number
3
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Active Ingredient
HEXAFLUORENIUM BROMIDE
Application Number
9789
Product Number
3
Dosage Form
-
Strength
20MG/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2014-03-06
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
204997
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2014-03-06
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2016-06-29
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
205014
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2016-06-29
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-06-09
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
213843
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-06-09
Regulatory Status
RX
Drug Name
NEOPASALATE
Product Number
2
Dosage Form
-
Strength
846MG;112MG
Approval Date
1982-01-01
Active Ingredient
AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID
Application Number
80059
Product Number
2
Dosage Form
-
Strength
846MG;112MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1993-12-30
Active Ingredient
GABAPENTIN
Application Number
20235
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1993-12-30
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1993-12-30
Active Ingredient
GABAPENTIN
Application Number
20235
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
1993-12-30
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1993-12-30
Active Ingredient
GABAPENTIN
Application Number
20235
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
1993-12-30
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1998-10-09
Active Ingredient
GABAPENTIN
Application Number
20882
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1998-10-09
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1998-10-09
Active Ingredient
GABAPENTIN
Application Number
20882
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
1998-10-09
Regulatory Status
RX
Drug Name
NEURONTIN
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-03-02
Active Ingredient
GABAPENTIN
Application Number
21129
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-03-02
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Active Ingredient
NEVIRAPINE
Application Number
202523
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2014-10-27
Active Ingredient
NEVIRAPINE
Application Number
205651
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2014-10-27
Regulatory Status
RX
Drug Name
NISOLDIPINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2008-07-25
Active Ingredient
NISOLDIPINE
Application Number
79051
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2008-07-25
Regulatory Status
Discontinued
Drug Name
NISOLDIPINE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2008-07-25
Active Ingredient
NISOLDIPINE
Application Number
79051
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2008-07-25
Regulatory Status
Discontinued
Drug Name
NISOLDIPINE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2008-07-25
Active Ingredient
NISOLDIPINE
Application Number
79051
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2008-07-25
Regulatory Status
Discontinued
Drug Name
NISOLDIPINE
Product Number
1
Dosage Form
-
Strength
8.5MG
Approval Date
2011-01-26
Active Ingredient
NISOLDIPINE
Application Number
91001
Product Number
1
Dosage Form
-
Strength
8.5MG
Approval Date
2011-01-26
Regulatory Status
Discontinued
Drug Name
NISOLDIPINE
Product Number
2
Dosage Form
-
Strength
17MG
Approval Date
2011-01-26
Active Ingredient
NISOLDIPINE
Application Number
91001
Product Number
2
Dosage Form
-
Strength
17MG
Approval Date
2011-01-26
Regulatory Status
Discontinued
Drug Name
NISOLDIPINE
Product Number
3
Dosage Form
-
Strength
25.5MG
Approval Date
2011-01-26
Active Ingredient
NISOLDIPINE
Application Number
91001
Product Number
3
Dosage Form
-
Strength
25.5MG
Approval Date
2011-01-26
Regulatory Status
Discontinued
Drug Name
NISOLDIPINE
Product Number
4
Dosage Form
-
Strength
34MG
Approval Date
2011-01-26
Active Ingredient
NISOLDIPINE
Application Number
91001
Product Number
4
Dosage Form
-
Strength
34MG
Approval Date
2011-01-26
Regulatory Status
Discontinued
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
1996-08-30
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
2
Dosage Form
-
Strength
0.4MG/HR
Approval Date
1996-08-30
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
2
Dosage Form
-
Strength
0.4MG/HR
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
3
Dosage Form
-
Strength
0.2MG/HR
Approval Date
1996-08-30
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
3
Dosage Form
-
Strength
0.2MG/HR
Approval Date
1996-08-30
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
4
Dosage Form
-
Strength
0.1MG/HR
Approval Date
1998-02-06
Active Ingredient
NITROGLYCERIN
Application Number
74559
Product Number
4
Dosage Form
-
Strength
0.1MG/HR
Approval Date
1998-02-06
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
1999-11-12
Active Ingredient
NITROGLYCERIN
Application Number
74992
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
1999-11-12
Regulatory Status
Discontinued
Drug Name
NITROGLYCERIN
Product Number
2
Dosage Form
-
Strength
0.4MG/HR
Approval Date
1999-11-12
Active Ingredient
NITROGLYCERIN
Application Number
74992
Product Number
2
Dosage Form
-
Strength
0.4MG/HR
Approval Date
1999-11-12
Regulatory Status
Discontinued
Drug Name
NITROGLYCERIN
Product Number
3
Dosage Form
-
Strength
0.2MG/HR
Approval Date
1999-11-12
Active Ingredient
NITROGLYCERIN
Application Number
74992
Product Number
3
Dosage Form
-
Strength
0.2MG/HR
Approval Date
1999-11-12
Regulatory Status
Discontinued
Drug Name
NITROGLYCERIN
Product Number
4
Dosage Form
-
Strength
0.1MG/HR
Approval Date
1999-11-12
Active Ingredient
NITROGLYCERIN
Application Number
74992
Product Number
4
Dosage Form
-
Strength
0.1MG/HR
Approval Date
1999-11-12
Regulatory Status
Discontinued
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.2MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
75073
Product Number
1
Dosage Form
-
Strength
0.2MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.4MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
75075
Product Number
1
Dosage Form
-
Strength
0.4MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.1MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
75076
Product Number
1
Dosage Form
-
Strength
0.1MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROSTAT
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2000-05-01
Active Ingredient
NITROGLYCERIN
Application Number
21134
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2000-05-01
Regulatory Status
RX
Drug Name
NITROSTAT
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2000-05-01
Active Ingredient
NITROGLYCERIN
Application Number
21134
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2000-05-01
Regulatory Status
RX
Drug Name
NITROSTAT
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2000-05-01
Active Ingredient
NITROGLYCERIN
Application Number
21134
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2000-05-01
Regulatory Status
RX
Drug Name
NIZATIDINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2002-07-09
Active Ingredient
NIZATIDINE
Application Number
75934
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2002-07-09
Regulatory Status
Discontinued
Drug Name
NIZATIDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2002-07-09
Active Ingredient
NIZATIDINE
Application Number
75934
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2002-07-09
Regulatory Status
Discontinued
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-10-04
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
211242
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2018-10-04
Regulatory Status
RX
Drug Name
NORETHINDRONE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date
2015-12-28
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
200486
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
Approval Date
2015-12-28
Regulatory Status
Discontinued
Drug Name
NORETHINDRONE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.035MG;0.5MG
Approval Date
2015-10-21
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
200488
Product Number
1
Dosage Form
-
Strength
0.035MG;0.5MG
Approval Date
2015-10-21
Regulatory Status
Discontinued
Drug Name
NORETHINDRONE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.035MG;1MG
Approval Date
2015-10-21
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
200489
Product Number
1
Dosage Form
-
Strength
0.035MG;1MG
Approval Date
2015-10-21
Regulatory Status
Discontinued
Drug Name
NORGESTIMATE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG
Approval Date
2016-01-27
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
201896
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG
Approval Date
2016-01-27
Regulatory Status
Discontinued
Drug Name
NORGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.03MG;0.3MG
Approval Date
2016-06-21
Active Ingredient
ETHINYL ESTRADIOL; NORGESTREL
Application Number
201828
Product Number
1
Dosage Form
-
Strength
0.03MG;0.3MG
Approval Date
2016-06-21
Regulatory Status
Discontinued
Drug Name
NORGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.05MG;0.5MG
Approval Date
2017-05-08
Active Ingredient
ETHINYL ESTRADIOL; NORGESTREL
Application Number
202875
Product Number
1
Dosage Form
-
Strength
0.05MG;0.5MG
Approval Date
2017-05-08
Regulatory Status
Discontinued
Drug Name
NORVASC
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-07-31
Active Ingredient
AMLODIPINE BESYLATE
Application Number
19787
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
1992-07-31
Regulatory Status
RX
Drug Name
NORVASC
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1992-07-31
Active Ingredient
AMLODIPINE BESYLATE
Application Number
19787
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1992-07-31
Regulatory Status
RX
Drug Name
NORVASC
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1992-07-31
Active Ingredient
AMLODIPINE BESYLATE
Application Number
19787
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1992-07-31
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
2025-12-12
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216589
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/VIAL
Approval Date
2025-12-12
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2025-12-12
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216589
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2025-12-12
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE/VIAL
Approval Date
2025-12-12
Active Ingredient
OCTREOTIDE ACETATE
Application Number
216589
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE/VIAL
Approval Date
2025-12-12
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Product Number
1
Dosage Form
-
Strength
EQ 0.05MG BASE/ML
Approval Date
2011-02-10
Active Ingredient
OCTREOTIDE ACETATE
Application Number
79198
Product Number
1
Dosage Form
-
Strength
EQ 0.05MG BASE/ML
Approval Date
2011-02-10
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Product Number
2
Dosage Form
-
Strength
EQ 0.1MG BASE/ML
Approval Date
2011-02-10
Active Ingredient
OCTREOTIDE ACETATE
Application Number
79198
Product Number
2
Dosage Form
-
Strength
EQ 0.1MG BASE/ML
Approval Date
2011-02-10
Regulatory Status
RX
Drug Name
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
Product Number
3
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
2011-02-10
Active Ingredient
OCTREOTIDE ACETATE
Application Number
79198
Product Number
3
Dosage Form
-
Strength
EQ 0.5MG BASE/ML
Approval Date
2011-02-10
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2012-08-07
Active Ingredient
OXALIPLATIN
Application Number
91358
Product Number
1
Dosage Form
-
Strength
50MG/10ML (5MG/ML)
Approval Date
2012-08-07
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2012-08-07
Active Ingredient
OXALIPLATIN
Application Number
91358
Product Number
2
Dosage Form
-
Strength
100MG/20ML (5MG/ML)
Approval Date
2012-08-07
Regulatory Status
RX
Drug Name
OXALIPLATIN
Product Number
3
Dosage Form
-
Strength
200MG/40ML (5MG/ML)
Approval Date
2017-11-14
Active Ingredient
OXALIPLATIN
Application Number
91358
Product Number
3
Dosage Form
-
Strength
200MG/40ML (5MG/ML)
Approval Date
2017-11-14
Regulatory Status
Discontinued
Drug Name
OXAPROZIN
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2001-02-28
Active Ingredient
OXAPROZIN
Application Number
75847
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2001-02-28
Regulatory Status
Discontinued
Drug Name
OXAZEPAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1987-10-20
Active Ingredient
OXAZEPAM
Application Number
71713
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1987-10-20
Regulatory Status
Discontinued
Drug Name
OXAZEPAM
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1987-10-20
Active Ingredient
OXAZEPAM
Application Number
71714
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1987-10-20
Regulatory Status
Discontinued
Drug Name
OXAZEPAM
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1987-10-20
Active Ingredient
OXAZEPAM
Application Number
71715
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
1987-10-20
Regulatory Status
Discontinued
Drug Name
Oxybutynin Chloride
Product Number
1
Dosage Form
-
Strength
15 MG.
Approval Date
-
Active Ingredient
Oxybutynin Chloride
Application Number
78293
Product Number
1
Dosage Form
-
Strength
15 MG.
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2025-08-19
Active Ingredient
PACLITAXEL
Application Number
217877
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2025-08-19
Regulatory Status
RX
Drug Name
PALIPERIDONE PALMITATE
Product Number
1
Dosage Form
-
Strength
273MG/0.88ML
Approval Date
-
Active Ingredient
PALIPERIDONE PALMITATE
Application Number
216228
Product Number
1
Dosage Form
-
Strength
273MG/0.88ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PALONOSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2018-09-19
Active Ingredient
PALONOSETRON HYDROCHLORIDE
Application Number
206416
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
Approval Date
2018-09-19
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
1
Dosage Form
-
Strength
30MG/10ML (3MG/ML)
Approval Date
2008-10-31
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
78520
Product Number
1
Dosage Form
-
Strength
30MG/10ML (3MG/ML)
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
PAMIDRONATE DISODIUM
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2008-10-31
Active Ingredient
PAMIDRONATE DISODIUM
Application Number
78520
Product Number
2
Dosage Form
-
Strength
90MG/10ML (9MG/ML)
Approval Date
2008-10-31
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2011-01-19
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
90970
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
90970
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2011-01-19
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
3
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2008-03-13
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
78902
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2008-03-13
Regulatory Status
RX
Drug Name
PENICILLIN G POTASSIUM
Product Number
1
Dosage Form
-
Strength
400,000 UNITS/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60752
Product Number
1
Dosage Form
-
Strength
400,000 UNITS/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
2
Dosage Form
-
Strength
250,000 UNITS/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60752
Product Number
2
Dosage Form
-
Strength
250,000 UNITS/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
3
Dosage Form
-
Strength
200,000 UNITS/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60752
Product Number
3
Dosage Form
-
Strength
200,000 UNITS/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
1
Dosage Form
-
Strength
200,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60781
Product Number
1
Dosage Form
-
Strength
200,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
2
Dosage Form
-
Strength
250,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60781
Product Number
2
Dosage Form
-
Strength
250,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
3
Dosage Form
-
Strength
400,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60781
Product Number
3
Dosage Form
-
Strength
400,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
4
Dosage Form
-
Strength
800,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60781
Product Number
4
Dosage Form
-
Strength
800,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN G POTASSIUM
Product Number
5
Dosage Form
-
Strength
500,000 UNITS
Approval Date
1982-01-01
Active Ingredient
PENICILLIN G POTASSIUM
Application Number
60781
Product Number
5
Dosage Form
-
Strength
500,000 UNITS
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN V POTASSIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61530
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN V POTASSIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61530
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN V POTASSIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61624
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PENICILLIN V POTASSIUM
Product Number
2
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
PENICILLIN V POTASSIUM
Application Number
61624
Product Number
2
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2017-04-14
Active Ingredient
PERPHENAZINE
Application Number
206691
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2017-04-14
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2017-04-14
Active Ingredient
PERPHENAZINE
Application Number
206691
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2017-04-14
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
2017-04-14
Active Ingredient
PERPHENAZINE
Application Number
206691
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
2017-04-14
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
2017-04-14
Active Ingredient
PERPHENAZINE
Application Number
206691
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
2017-04-14
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;2MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
70336
Product Number
1
Dosage Form
-
Strength
10MG;2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG;2MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
70337
Product Number
1
Dosage Form
-
Strength
25MG;2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG;4MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
70338
Product Number
1
Dosage Form
-
Strength
25MG;4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;4MG
Approval Date
-
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71442
Product Number
1
Dosage Form
-
Strength
10MG;4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG;4MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
1
Dosage Form
-
Strength
50MG;4MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG;2MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
2
Dosage Form
-
Strength
10MG;2MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG;4MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
3
Dosage Form
-
Strength
10MG;4MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
25MG;2MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
4
Dosage Form
-
Strength
25MG;2MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
25MG;4MG
Approval Date
1988-11-10
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
Application Number
71443
Product Number
5
Dosage Form
-
Strength
25MG;4MG
Approval Date
1988-11-10
Regulatory Status
RX
Drug Name
PHENYTEK
Product Number
2
Dosage Form
-
Strength
200MG EXTENDED
Approval Date
2001-12-06
Active Ingredient
PHENYTOIN SODIUM
Application Number
40298
Product Number
2
Dosage Form
-
Strength
200MG EXTENDED
Approval Date
2001-12-06
Regulatory Status
RX
Drug Name
PHENYTEK
Product Number
3
Dosage Form
-
Strength
300MG EXTENDED
Approval Date
2001-12-06
Active Ingredient
PHENYTOIN SODIUM
Application Number
40298
Product Number
3
Dosage Form
-
Strength
300MG EXTENDED
Approval Date
2001-12-06
Regulatory Status
RX
Drug Name
PINDOLOL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1992-09-24
Active Ingredient
PINDOLOL
Application Number
74013
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1992-09-24
Regulatory Status
Discontinued
Drug Name
PINDOLOL
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1992-09-24
Active Ingredient
PINDOLOL
Application Number
74018
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1992-09-24
Regulatory Status
Discontinued
Drug Name
PIROXICAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1992-09-22
Active Ingredient
PIROXICAM
Application Number
74043
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1992-09-22
Regulatory Status
Discontinued
Drug Name
PIROXICAM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1992-09-22
Active Ingredient
PIROXICAM
Application Number
74043
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
1992-09-22
Regulatory Status
Discontinued
Drug Name
PITAVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2019-04-04
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206070
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2019-04-04
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2019-04-04
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206070
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2019-04-04
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2019-04-04
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206070
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2019-04-04
Regulatory Status
RX
Drug Name
POLYETHYLENE GLYCOL 3350
Product Number
1
Dosage Form
-
Strength
17GM/PACKET
Approval Date
2009-10-06
Active Ingredient
POLYETHYLENE GLYCOL 3350
Application Number
78915
Product Number
1
Dosage Form
-
Strength
17GM/PACKET
Approval Date
2009-10-06
Regulatory Status
OTC
Drug Name
POLYETHYLENE GLYCOL 3350
Product Number
2
Dosage Form
-
Strength
17GM/SCOOPFUL
Approval Date
2009-10-06
Active Ingredient
POLYETHYLENE GLYCOL 3350
Application Number
78915
Product Number
2
Dosage Form
-
Strength
17GM/SCOOPFUL
Approval Date
2009-10-06
Regulatory Status
OTC
Drug Name
POMALIDOMIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2022-01-26
Active Ingredient
POMALIDOMIDE
Application Number
210275
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2022-01-26
Regulatory Status
Discontinued
Drug Name
POMALIDOMIDE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2022-01-26
Active Ingredient
POMALIDOMIDE
Application Number
210275
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2022-01-26
Regulatory Status
Discontinued
Drug Name
POMALIDOMIDE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2022-01-26
Active Ingredient
POMALIDOMIDE
Application Number
210275
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2022-01-26
Regulatory Status
Discontinued
Drug Name
POMALIDOMIDE
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
2022-01-26
Active Ingredient
POMALIDOMIDE
Application Number
210275
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
2022-01-26
Regulatory Status
Discontinued
Drug Name
POSACONAZOLE
Product Number
1
Dosage Form
-
Strength
300MG/16.7ML (18MG/ML)
Approval Date
2023-12-26
Active Ingredient
POSACONAZOLE
Application Number
211500
Product Number
1
Dosage Form
-
Strength
300MG/16.7ML (18MG/ML)
Approval Date
2023-12-26
Regulatory Status
RX
Drug Name
PRASUGREL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-07-12
Active Ingredient
PRASUGREL HYDROCHLORIDE
Application Number
205927
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-07-12
Regulatory Status
RX
Drug Name
PRASUGREL
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-07-12
Active Ingredient
PRASUGREL HYDROCHLORIDE
Application Number
205927
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-07-12
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
-
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72573
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
-
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72574
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1989-05-16
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72575
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1989-05-16
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1989-05-16
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72575
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1989-05-16
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1989-05-16
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
72575
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1989-05-16
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
83677
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Active Ingredient
PREDNISONE
Application Number
83677
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PREDNISONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1985-12-04
Active Ingredient
PREDNISONE
Application Number
83677
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1985-12-04
Regulatory Status
RX
Drug Name
PROCHLORPERAZINE EDISYLATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2018-10-25
Active Ingredient
PROCHLORPERAZINE EDISYLATE
Application Number
210710
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2018-10-25
Regulatory Status
RX
Drug Name
PROCTOFOAM HC
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Active Ingredient
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
Application Number
86195
Product Number
1
Dosage Form
-
Strength
1%;1%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2002-11-21
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
40471
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2002-11-21
Regulatory Status
Discontinued
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
225MG
Approval Date
2016-04-29
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
203803
Product Number
1
Dosage Form
-
Strength
225MG
Approval Date
2016-04-29
Regulatory Status
Discontinued
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
325MG
Approval Date
2016-04-29
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
203803
Product Number
2
Dosage Form
-
Strength
325MG
Approval Date
2016-04-29
Regulatory Status
Discontinued
Drug Name
PROPAFENONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
425MG
Approval Date
2016-04-29
Active Ingredient
PROPAFENONE HYDROCHLORIDE
Application Number
203803
Product Number
3
Dosage Form
-
Strength
425MG
Approval Date
2016-04-29
Regulatory Status
Discontinued
Drug Name
PROPANTHELINE BROMIDE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Active Ingredient
PROPANTHELINE BROMIDE
Application Number
83706
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
2004-12-16
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
40569
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
2004-12-16
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
83299
Product Number
1
Dosage Form
-
Strength
65MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
32MG
Approval Date
1982-01-01
Active Ingredient
PROPOXYPHENE HYDROCHLORIDE
Application Number
83528
Product Number
1
Dosage Form
-
Strength
32MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;32MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
Application Number
83689
Product Number
1
Dosage Form
-
Strength
325MG;32MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;65MG
Approval Date
1982-01-01
Active Ingredient
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
Application Number
83978
Product Number
1
Dosage Form
-
Strength
650MG;65MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;100MG
Approval Date
1985-06-12
Active Ingredient
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Application Number
70145
Product Number
1
Dosage Form
-
Strength
650MG;100MG
Approval Date
1985-06-12
Regulatory Status
Discontinued
Drug Name
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
650MG;100MG
Approval Date
1988-02-16
Active Ingredient
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Application Number
72195
Product Number
1
Dosage Form
-
Strength
650MG;100MG
Approval Date
1988-02-16
Regulatory Status
Discontinued
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
1985-11-19
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
1985-11-19
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2011-04-08
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
70213
Product Number
5
Dosage Form
-
Strength
60MG
Approval Date
2011-04-08
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1989-06-09
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
72275
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
1989-06-09
Regulatory Status
Discontinued
Drug Name
PYRIDOXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2016-07-14
Active Ingredient
PYRIDOXINE HYDROCHLORIDE
Application Number
204879
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2016-07-14
Regulatory Status
Discontinued
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-01-28
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
76036
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2005-01-28
Regulatory Status
Discontinued
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2005-01-28
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
76036
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2005-01-28
Regulatory Status
Discontinued
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2005-01-28
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
76036
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2005-01-28
Regulatory Status
Discontinued
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2005-01-28
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
76036
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2005-01-28
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1997-08-22
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
74023
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
1997-08-22
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1997-08-22
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
74023
Product Number
2
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
1997-08-22
Regulatory Status
Discontinued
Drug Name
RANITIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
2016-06-09
Active Ingredient
RANITIDINE HYDROCHLORIDE
Application Number
79076
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/ML
Approval Date
2016-06-09
Regulatory Status
Discontinued
Drug Name
REGADENOSON
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2023-04-04
Active Ingredient
REGADENOSON
Application Number
213856
Product Number
1
Dosage Form
-
Strength
0.4MG/5ML (0.08MG/ML)
Approval Date
2023-04-04
Regulatory Status
Discontinued
Drug Name
RESERPINE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Active Ingredient
RESERPINE
Application Number
84974
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
REVATIO
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2005-06-03
Active Ingredient
SILDENAFIL CITRATE
Application Number
21845
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2005-06-03
Regulatory Status
RX
Drug Name
REVATIO
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date
2009-11-18
Active Ingredient
SILDENAFIL CITRATE
Application Number
22473
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
Approval Date
2009-11-18
Regulatory Status
RX
Drug Name
REVATIO
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2012-08-30
Active Ingredient
SILDENAFIL CITRATE
Application Number
203109
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2012-08-30
Regulatory Status
Discontinued
Drug Name
RIFAMPIN
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2008-05-22
Active Ingredient
RIFAMPIN
Application Number
65421
Product Number
1
Dosage Form
-
Strength
600MG/VIAL
Approval Date
2008-05-22
Regulatory Status
RX
Drug Name
RIMSO-50
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
1982-01-01
Active Ingredient
DIMETHYL SULFOXIDE
Application Number
17788
Product Number
1
Dosage Form
-
Strength
50%
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
RITONAVIR
Application Number
202738
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
-
Active Ingredient
RIVAROXABAN
Application Number
212220
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RIVASTIGMINE
Product Number
1
Dosage Form
-
Strength
4.6MG/24HR
Approval Date
2018-06-20
Active Ingredient
RIVASTIGMINE
Application Number
205622
Product Number
1
Dosage Form
-
Strength
4.6MG/24HR
Approval Date
2018-06-20
Regulatory Status
RX
Drug Name
RIVASTIGMINE
Product Number
2
Dosage Form
-
Strength
9.5MG/24HR
Approval Date
2018-06-20
Active Ingredient
RIVASTIGMINE
Application Number
205622
Product Number
2
Dosage Form
-
Strength
9.5MG/24HR
Approval Date
2018-06-20
Regulatory Status
RX
Drug Name
RIVASTIGMINE
Product Number
3
Dosage Form
-
Strength
13.3MG/24HR
Approval Date
2018-06-20
Active Ingredient
RIVASTIGMINE
Application Number
205622
Product Number
3
Dosage Form
-
Strength
13.3MG/24HR
Approval Date
2018-06-20
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-11-26
Active Ingredient
ROCURONIUM BROMIDE
Application Number
79199
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2008-11-26
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2008-11-26
Active Ingredient
ROCURONIUM BROMIDE
Application Number
79199
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2008-11-26
Regulatory Status
RX
Drug Name
RONDOMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 140MG BASE
Approval Date
1982-01-01
Active Ingredient
METHACYCLINE HYDROCHLORIDE
Application Number
60641
Product Number
1
Dosage Form
-
Strength
EQ 140MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RONDOMYCIN
Product Number
2
Dosage Form
-
Strength
EQ 280MG BASE
Approval Date
1982-01-01
Active Ingredient
METHACYCLINE HYDROCHLORIDE
Application Number
60641
Product Number
2
Dosage Form
-
Strength
EQ 280MG BASE
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
RONDOMYCIN
Product Number
3
Dosage Form
-
Strength
EQ 70MG BASE/5ML
Approval Date
1982-01-01
Active Ingredient
METHACYCLINE HYDROCHLORIDE
Application Number
60641
Product Number
3
Dosage Form
-
Strength
EQ 70MG BASE/5ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2023-10-26
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
206091
Product Number
1
Dosage Form
-
Strength
200MG/100ML (2MG/ML)
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
ROPIVACAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2023-10-26
Active Ingredient
ROPIVACAINE HYDROCHLORIDE
Application Number
206091
Product Number
2
Dosage Form
-
Strength
400MG/200ML (2MG/ML)
Approval Date
2023-10-26
Regulatory Status
RX
Drug Name
ROWASA
Product Number
1
Dosage Form
-
Strength
4GM/60ML
Approval Date
1987-12-24
Active Ingredient
MESALAMINE
Application Number
19618
Product Number
1
Dosage Form
-
Strength
4GM/60ML
Approval Date
1987-12-24
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
205980
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
205980
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG;EQ 5MG BASE
Approval Date
2023-07-31
Active Ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Application Number
205981
Product Number
1
Dosage Form
-
Strength
500MG;EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM;EQ 2.5MG BASE
Approval Date
2023-07-31
Active Ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Application Number
205981
Product Number
2
Dosage Form
-
Strength
1GM;EQ 2.5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1GM;EQ 5MG BASE
Approval Date
2023-07-31
Active Ingredient
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
Application Number
205981
Product Number
3
Dosage Form
-
Strength
1GM;EQ 5MG BASE
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
SCOPOLAMINE
Product Number
1
Dosage Form
-
Strength
1MG/72HR
Approval Date
2019-06-19
Active Ingredient
SCOPOLAMINE
Application Number
203753
Product Number
1
Dosage Form
-
Strength
1MG/72HR
Approval Date
2019-06-19
Regulatory Status
RX
Drug Name
SEMGLEE
Product Number
1
Dosage Form
-
Strength
100 UNITS/ML
Approval Date
-
Active Ingredient
INSULIN GLARGINE
Application Number
210605
Product Number
1
Dosage Form
-
Strength
100 UNITS/ML
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SEMGLEE
Product Number
1
Dosage Form
-
Strength
10ML(100UNITS/ML)
Approval Date
-
Active Ingredient
INSULIN GLARGINE-YFGN
Application Number
761201
Product Number
1
Dosage Form
-
Strength
10ML(100UNITS/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SEMGLEE
Product Number
2
Dosage Form
-
Strength
3ML(100UNITS/ML)
Approval Date
-
Active Ingredient
INSULIN GLARGINE-YFGN
Application Number
761201
Product Number
2
Dosage Form
-
Strength
3ML(100UNITS/ML)
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-03-20
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
76540
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-03-20
Regulatory Status
Discontinued
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-03-20
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
76540
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-03-20
Regulatory Status
Discontinued
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-03-20
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
76540
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-03-20
Regulatory Status
Discontinued
Drug Name
SFROWASA
Product Number
2
Dosage Form
-
Strength
4GM/60ML
Approval Date
2008-06-20
Active Ingredient
MESALAMINE
Application Number
19618
Product Number
2
Dosage Form
-
Strength
4GM/60ML
Approval Date
2008-06-20
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-11-09
Active Ingredient
SILDENAFIL CITRATE
Application Number
201150
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-11-09
Regulatory Status
Discontinued
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2019-03-25
Active Ingredient
SILDENAFIL CITRATE
Application Number
201171
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2019-03-25
Regulatory Status
Discontinued
Drug Name
SILDENAFIL CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2019-03-25
Active Ingredient
SILDENAFIL CITRATE
Application Number
201171
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2019-03-25
Regulatory Status
Discontinued
Drug Name
SILDENAFIL CITRATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2019-03-25
Active Ingredient
SILDENAFIL CITRATE
Application Number
201171
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2019-03-25
Regulatory Status
Discontinued
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202473
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202473
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
202473
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SODIUM NITROPRUSSIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2018-04-17
Active Ingredient
SODIUM NITROPRUSSIDE
Application Number
210763
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2018-04-17
Regulatory Status
RX
Drug Name
SOMA
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1982-01-01
Active Ingredient
CARISOPRODOL
Application Number
11792
Product Number
1
Dosage Form
-
Strength
350MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SOMA
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Active Ingredient
CARISOPRODOL
Application Number
11792
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
SOMA
Product Number
4
Dosage Form
-
Strength
250MG
Approval Date
2007-09-13
Active Ingredient
CARISOPRODOL
Application Number
11792
Product Number
4
Dosage Form
-
Strength
250MG
Approval Date
2007-09-13
Regulatory Status
RX
Drug Name
SORAFENIB TOSYLATE
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2020-09-10
Active Ingredient
SORAFENIB TOSYLATE
Application Number
207012
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2020-09-10
Regulatory Status
RX
Drug Name
SOTRADECOL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2004-11-12
Active Ingredient
SODIUM TETRADECYL SULFATE
Application Number
40541
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2004-11-12
Regulatory Status
RX
Drug Name
SOTRADECOL
Product Number
2
Dosage Form
-
Strength
60MG/2ML (30MG/ML)
Approval Date
2004-11-12
Active Ingredient
SODIUM TETRADECYL SULFATE
Application Number
40541
Product Number
2
Dosage Form
-
Strength
60MG/2ML (30MG/ML)
Approval Date
2004-11-12
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2001-08-20
Active Ingredient
SPIRONOLACTONE
Application Number
40424
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2001-08-20
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2001-08-20
Active Ingredient
SPIRONOLACTONE
Application Number
40424
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2001-08-20
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2001-08-20
Active Ingredient
SPIRONOLACTONE
Application Number
40424
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2001-08-20
Regulatory Status
RX
Drug Name
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;25MG
Approval Date
1982-01-01
Active Ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Application Number
86513
Product Number
1
Dosage Form
-
Strength
25MG;25MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SUCRALFATE
Product Number
1
Dosage Form
-
Strength
1GM/10ML
Approval Date
2022-09-12
Active Ingredient
SUCRALFATE
Application Number
212913
Product Number
1
Dosage Form
-
Strength
1GM/10ML
Approval Date
2022-09-12
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
213915
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
213915
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SULFAMYLON
Product Number
3
Dosage Form
-
Strength
5%
Approval Date
1998-06-05
Active Ingredient
MAFENIDE ACETATE
Application Number
19832
Product Number
3
Dosage Form
-
Strength
5%
Approval Date
1998-06-05
Regulatory Status
Discontinued
Drug Name
SULINDAC
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
SULINDAC
Application Number
73038
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2009-11-02
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77163
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2009-11-02
Regulatory Status
Discontinued
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2009-11-02
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77163
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2009-11-02
Regulatory Status
Discontinued
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-11-02
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77163
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-11-02
Regulatory Status
Discontinued
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2009-08-10
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
77744
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
77744
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
77744
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2009-08-10
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-12-06
Active Ingredient
SUNITINIB MALATE
Application Number
201275
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-12-06
Regulatory Status
RX
Drug Name
SYMFI
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
2018-03-22
Active Ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
22142
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
2018-03-22
Regulatory Status
RX
Drug Name
SYMFI LO
Product Number
1
Dosage Form
-
Strength
400MG;300MG;300MG
Approval Date
2018-02-05
Active Ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
208255
Product Number
1
Dosage Form
-
Strength
400MG;300MG;300MG
Approval Date
2018-02-05
Regulatory Status
Discontinued
Drug Name
TACROLIMUS
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2010-09-17
Active Ingredient
TACROLIMUS
Application Number
90596
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2010-09-17
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-09-17
Active Ingredient
TACROLIMUS
Application Number
90596
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-09-17
Regulatory Status
RX
Drug Name
TACROLIMUS
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2010-09-17
Active Ingredient
TACROLIMUS
Application Number
90596
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2010-09-17
Regulatory Status
RX
Drug Name
TAMOXIFEN CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2003-02-20
Active Ingredient
TAMOXIFEN CITRATE
Application Number
74732
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2003-02-20
Regulatory Status
RX
Drug Name
TAMOXIFEN CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2003-02-20
Active Ingredient
TAMOXIFEN CITRATE
Application Number
74732
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2003-02-20
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
202397
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
202397
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
202397
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
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2014-08-26
Regulatory Status
RX
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2014-08-26
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
202516
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2014-08-26
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
77136
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2007-07-02
Regulatory Status
Discontinued
Drug Name
TETRABENAZINE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2017-01-31
Active Ingredient
TETRABENAZINE
Application Number
207682
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2017-01-31
Regulatory Status
RX
Drug Name
TETRABENAZINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2017-01-31
Active Ingredient
TETRABENAZINE
Application Number
207682
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2017-01-31
Regulatory Status
RX
Drug Name
THIAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2012-06-25
Active Ingredient
THIAMINE HYDROCHLORIDE
Application Number
91623
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2012-06-25
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1983-11-18
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1983-11-18
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1983-03-15
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1983-03-15
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1983-03-15
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
1983-03-15
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
1983-03-15
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88004
Product Number
4
Dosage Form
-
Strength
50MG
Approval Date
1983-03-15
Regulatory Status
RX
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1983-06-27
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88332
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
1983-06-27
Regulatory Status
Discontinued
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1983-06-27
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88333
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1983-06-27
Regulatory Status
Discontinued
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1983-06-27
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88334
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
1983-06-27
Regulatory Status
Discontinued
Drug Name
THIORIDAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1983-11-18
Active Ingredient
THIORIDAZINE HYDROCHLORIDE
Application Number
88335
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1983-11-18
Regulatory Status
Discontinued
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2021-07-09
Active Ingredient
TICAGRELOR
Application Number
208597
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2021-07-09
Active Ingredient
TICAGRELOR
Application Number
208597
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2021-07-09
Regulatory Status
RX
Drug Name
TICLOPIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1999-09-13
Active Ingredient
TICLOPIDINE HYDROCHLORIDE
Application Number
75161
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
1999-09-13
Regulatory Status
Discontinued
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1990-06-08
Active Ingredient
TIMOLOL MALEATE
Application Number
72668
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
1990-06-08
Regulatory Status
Discontinued
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1990-06-08
Active Ingredient
TIMOLOL MALEATE
Application Number
72668
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
1990-06-08
Regulatory Status
Discontinued
Drug Name
TIMOLOL MALEATE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1990-06-08
Active Ingredient
TIMOLOL MALEATE
Application Number
72668
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
1990-06-08
Regulatory Status
RX
Drug Name
TOBI
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
1997-12-22
Active Ingredient
TOBRAMYCIN
Application Number
50753
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
1997-12-22
Regulatory Status
RX
Drug Name
TOBI PODHALER
Product Number
1
Dosage Form
-
Strength
28MG
Approval Date
2013-03-22
Active Ingredient
TOBRAMYCIN
Application Number
201688
Product Number
1
Dosage Form
-
Strength
28MG
Approval Date
2013-03-22
Regulatory Status
RX
Drug Name
TOBRAMYCIN SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2008-03-11
Active Ingredient
TOBRAMYCIN SULFATE
Application Number
65407
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/ML
Approval Date
2008-03-11
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2002-11-21
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
75980
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2002-11-21
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2002-06-21
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
75986
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2002-06-21
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2015-12-22
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
205257
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2015-12-22
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2015-12-22
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
205257
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2015-12-22
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2015-12-22
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
205257
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2015-12-22
Regulatory Status
Discontinued
Drug Name
TRANEXAMIC ACID
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2011-11-03
Active Ingredient
TRANEXAMIC ACID
Application Number
91657
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2011-11-03
Regulatory Status
RX
Drug Name
TRAVOPROST
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2017-07-07
Active Ingredient
TRAVOPROST
Application Number
205050
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2017-07-07
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2015-08-13
Active Ingredient
TRETINOIN
Application Number
207955
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2015-08-13
Regulatory Status
RX
Drug Name
TRIAMCINOLONE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Active Ingredient
TRIAMCINOLONE
Application Number
84406
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-11-02
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
212567
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2022-11-02
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
TRIFLUOPERAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1997-07-07
Active Ingredient
TRIFLUOPERAZINE HYDROCHLORIDE
Application Number
40209
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1997-07-07
Regulatory Status
RX
Drug Name
ULTIVA
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL
Approval Date
1996-07-12
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
20630
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/VIAL
Approval Date
1996-07-12
Regulatory Status
RX
Drug Name
ULTIVA
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE/VIAL
Approval Date
1996-07-12
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
20630
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE/VIAL
Approval Date
1996-07-12
Regulatory Status
RX
Drug Name
ULTIVA
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE/VIAL
Approval Date
1996-07-12
Active Ingredient
REMIFENTANIL HYDROCHLORIDE
Application Number
20630
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE/VIAL
Approval Date
1996-07-12
Regulatory Status
RX
Drug Name
UNITENSEN
Product Number
1
Dosage Form
-
Strength
260CSR UNIT/ML
Approval Date
1982-01-01
Active Ingredient
CRYPTENAMINE ACETATES
Application Number
8814
Product Number
1
Dosage Form
-
Strength
260CSR UNIT/ML
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
UNITENSEN
Product Number
1
Dosage Form
-
Strength
260CSR UNIT
Approval Date
1982-01-01
Active Ingredient
CRYPTENAMINE TANNATES
Application Number
9217
Product Number
1
Dosage Form
-
Strength
260CSR UNIT
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VALACYCLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2010-05-24
Active Ingredient
VALACYCLOVIR HYDROCHLORIDE
Application Number
78518
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
78518
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE
Approval Date
2010-05-24
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
90866
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
90866
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
90866
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
90866
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
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;160MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
3
Dosage Form
-
Strength
25MG;160MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
4
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2012-09-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
78020
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2012-09-21
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-12-30
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
65397
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2008-12-30
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-12-30
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
65397
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/VIAL
Approval Date
2008-12-30
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2008-12-30
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
65432
Product Number
1
Dosage Form
-
Strength
EQ 5GM BASE/VIAL
Approval Date
2008-12-30
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2011-07-01
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
91469
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2011-07-01
Regulatory Status
Discontinued
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2011-09-19
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
91554
Product Number
1
Dosage Form
-
Strength
EQ 10GM BASE/VIAL
Approval Date
2011-09-19
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2018-07-10
Regulatory Status
Discontinued
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
2
Dosage Form
-
Strength
EQ 750MG BASE/VIAL
Approval Date
2018-07-10
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
3
Dosage Form
-
Strength
EQ 1.25GM BASE/VIAL
Approval Date
2018-07-10
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2018-07-10
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
4
Dosage Form
-
Strength
EQ 1.5GM BASE/VIAL
Approval Date
2018-07-10
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 1.75GM BASE/VIAL
Approval Date
2024-06-26
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
5
Dosage Form
-
Strength
EQ 1.75GM BASE/VIAL
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
VANCOMYCIN HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2024-06-26
Active Ingredient
VANCOMYCIN HYDROCHLORIDE
Application Number
209481
Product Number
6
Dosage Form
-
Strength
EQ 2GM BASE/VIAL
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2010-05-11
Active Ingredient
VECURONIUM BROMIDE
Application Number
90243
Product Number
1
Dosage Form
-
Strength
10MG/VIAL
Approval Date
2010-05-11
Regulatory Status
RX
Drug Name
VECURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2010-05-11
Active Ingredient
VECURONIUM BROMIDE
Application Number
90243
Product Number
2
Dosage Form
-
Strength
20MG/VIAL
Approval Date
2010-05-11
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
1999-04-20
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
75138
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
1999-04-20
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
1999-04-20
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
75138
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
1999-04-20
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
1999-04-20
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
75138
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
1999-04-20
Regulatory Status
RX
Drug Name
VERTAVIS
Product Number
2
Dosage Form
-
Strength
130CSR UNIT
Approval Date
1982-01-01
Active Ingredient
VERATRUM VIRIDE ROOT
Application Number
5691
Product Number
2
Dosage Form
-
Strength
130CSR UNIT
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
VIAGRA
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1998-03-27
Active Ingredient
SILDENAFIL CITRATE
Application Number
20895
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1998-03-27
Regulatory Status
RX
Drug Name
VIAGRA
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1998-03-27
Active Ingredient
SILDENAFIL CITRATE
Application Number
20895
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1998-03-27
Regulatory Status
RX
Drug Name
VIAGRA
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1998-03-27
Active Ingredient
SILDENAFIL CITRATE
Application Number
20895
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1998-03-27
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2010-04-22
Active Ingredient
VORICONAZOLE
Application Number
90547
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2010-04-22
Regulatory Status
RX
Drug Name
VORICONAZOLE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2010-04-22
Active Ingredient
VORICONAZOLE
Application Number
90547
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2010-04-22
Regulatory Status
RX
Drug Name
VUSION
Product Number
1
Dosage Form
-
Strength
0.25%;81.35%;15%
Approval Date
2006-02-16
Active Ingredient
MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE
Application Number
21026
Product Number
1
Dosage Form
-
Strength
0.25%;81.35%;15%
Approval Date
2006-02-16
Regulatory Status
RX
Drug Name
WAMPOCAP
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Active Ingredient
NIACIN
Application Number
11073
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
WIXELA INHUB
Product Number
1
Dosage Form
-
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
208891
Product Number
1
Dosage Form
-
Strength
0.1MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
WIXELA INHUB
Product Number
2
Dosage Form
-
Strength
0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
208891
Product Number
2
Dosage Form
-
Strength
0.25MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
WIXELA INHUB
Product Number
3
Dosage Form
-
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Active Ingredient
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Application Number
208891
Product Number
3
Dosage Form
-
Strength
0.5MG/INH;EQ 0.05MG BASE/INH
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
XULANE
Product Number
1
Dosage Form
-
Strength
0.035MG/24HR;0.15MG/24HR
Approval Date
2014-04-16
Active Ingredient
ETHINYL ESTRADIOL; NORELGESTROMIN
Application Number
200910
Product Number
1
Dosage Form
-
Strength
0.035MG/24HR;0.15MG/24HR
Approval Date
2014-04-16
Regulatory Status
RX
Drug Name
ZAGAM
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1996-12-19
Active Ingredient
SPARFLOXACIN
Application Number
20677
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
1996-12-19
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-10-10
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
202395
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-10-10
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-10-10
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
202395
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-10-10
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-10-10
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
202395
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-10-10
Regulatory Status
Discontinued
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2013-10-10
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
202395
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2013-10-10
Regulatory Status
Discontinued
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-03-04
Active Ingredient
ZOLEDRONIC ACID
Application Number
202650
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2013-03-04
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-02-14
Active Ingredient
ZOLEDRONIC ACID
Application Number
203841
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-02-14
Regulatory Status
RX
Drug Name
ZOLEDRONIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-10-27
Active Ingredient
ZOLEDRONIC ACID
Application Number
205254
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/100ML
Approval Date
2017-10-27
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1991-12-30
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
1991-12-30
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1991-12-30
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
1991-12-30
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-12-30
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-12-30
Regulatory Status
Discontinued
Drug Name
ZOLOFT
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-12-30
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1991-12-30
Regulatory Status
Discontinued
Drug Name
ZOLOFT
Product Number
5
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1996-03-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
19839
Product Number
5
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
1996-03-06
Regulatory Status
RX
Drug Name
ZOLOFT
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
1999-12-07
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
20990
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/ML
Approval Date
1999-12-07
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-04-23
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
78016
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2007-04-23
Regulatory Status
Discontinued
Drug Name
ZOLPIDEM TARTRATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-04-23
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
78016
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2007-04-23
Regulatory Status
Discontinued
Drug Name
ZONALON
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
1994-04-01
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
20126
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
1994-04-01
Regulatory Status
RX
Drug Status Breakdown
922 total- RX
- Unclassified
- Discontinued
- OTC
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
ABACAVIR SULFATE
Application Number
91294
Product Number
1
Active Ingredient
ABACAVIR SULFATE
Dosage Form
-
Strength
EQ 300MG BASE
FDA Approved Drug Data
Approved drug product information
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