Alembic Pharmaceuticals Limited
FDA Approved Drugs
Alembic Pharmaceuticals Limited
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 533
- Latest Approval Date Jul 27, 2026
- Data Source FDA
- First Approval Date Jan 12, 2009
Company Overview
Company
Alembic Pharmaceuticals Limited
Country
India
Website
Social Profiles
Company Snapshot
Alembic Pharmaceuticals Limited
Alembic Road, Vadodara - 390 003, Gujarat
India
www.alembic-india.com/ infoal@alembic.co.in View on MapFDA Approved Drug Records ( 533 records )
Drug Name
ACALABRUTINIB
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
ACALABRUTINIB
Application Number
216775
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ACETAZOLAMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2019-02-19
Active Ingredient
ACETAZOLAMIDE
Application Number
210423
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2019-02-19
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-08-05
Active Ingredient
ACITRETIN
Application Number
217774
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-08-05
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
2
Dosage Form
-
Strength
17.5MG
Approval Date
2024-08-05
Active Ingredient
ACITRETIN
Application Number
217774
Product Number
2
Dosage Form
-
Strength
17.5MG
Approval Date
2024-08-05
Regulatory Status
RX
Drug Name
ACITRETIN
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
2024-08-05
Active Ingredient
ACITRETIN
Application Number
217774
Product Number
3
Dosage Form
-
Strength
25MG
Approval Date
2024-08-05
Regulatory Status
RX
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2018-04-06
Active Ingredient
ACYCLOVIR
Application Number
209000
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2018-04-06
Regulatory Status
RX
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2023-11-21
Active Ingredient
ACYCLOVIR
Application Number
212361
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2023-11-21
Regulatory Status
RX
Drug Name
ADAPALENE
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2020-06-18
Active Ingredient
ADAPALENE
Application Number
213508
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2020-06-18
Regulatory Status
RX
Drug Name
ADAPALENE AND BENZOYL PEROXIDE
Product Number
1
Dosage Form
-
Strength
0.3%;2.5%
Approval Date
2022-08-04
Active Ingredient
ADAPALENE; BENZOYL PEROXIDE
Application Number
214185
Product Number
1
Dosage Form
-
Strength
0.3%;2.5%
Approval Date
2022-08-04
Regulatory Status
RX
Drug Name
ALBENDAZOLE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-09-04
Active Ingredient
ALBENDAZOLE
Application Number
215652
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-09-04
Regulatory Status
RX
Drug Name
ALCAFTADINE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2024-10-02
Active Ingredient
ALCAFTADINE
Application Number
209290
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2024-10-02
Regulatory Status
OTC
Drug Name
AMANTADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2017-06-21
Active Ingredient
AMANTADINE HYDROCHLORIDE
Application Number
208966
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2017-06-21
Regulatory Status
RX
Drug Name
AMANTADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2020-10-15
Active Ingredient
AMANTADINE HYDROCHLORIDE
Application Number
214284
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2020-10-15
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2017-07-17
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207073
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2017-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2017-07-17
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207073
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2017-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2017-07-17
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207073
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2017-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2017-07-17
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207073
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2017-07-17
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 10MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 10MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 20MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
2
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 20MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 40MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE;EQ 40MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;EQ 10MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
4
Dosage Form
-
Strength
EQ 5MG BASE;EQ 10MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;EQ 20MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
5
Dosage Form
-
Strength
EQ 5MG BASE;EQ 20MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
6
Dosage Form
-
Strength
EQ 5MG BASE;EQ 40MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
6
Dosage Form
-
Strength
EQ 5MG BASE;EQ 40MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;EQ 80MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE;EQ 80MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
8
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
8
Dosage Form
-
Strength
EQ 10MG BASE;EQ 10MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
9
Dosage Form
-
Strength
EQ 10MG BASE;EQ 20MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
9
Dosage Form
-
Strength
EQ 10MG BASE;EQ 20MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
10
Dosage Form
-
Strength
EQ 10MG BASE;EQ 40MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
10
Dosage Form
-
Strength
EQ 10MG BASE;EQ 40MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Product Number
11
Dosage Form
-
Strength
EQ 10MG BASE;EQ 80MG BASE
Approval Date
2025-05-22
Active Ingredient
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
Application Number
217279
Product Number
11
Dosage Form
-
Strength
EQ 10MG BASE;EQ 80MG BASE
Approval Date
2025-05-22
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-04-03
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202713
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2015-04-03
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-04-03
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202713
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2015-04-03
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-04-03
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202713
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2015-04-03
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-04-03
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
202713
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2015-04-03
Regulatory Status
RX
Drug Name
ARFORMOTEROL TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2022-05-10
Active Ingredient
ARFORMOTEROL TARTRATE
Application Number
214779
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2022-05-10
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202101
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202101
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202101
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202101
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202101
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202101
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202102
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2015-04-28
Active Ingredient
ARIPIPRAZOLE
Application Number
202102
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2015-04-28
Regulatory Status
RX
Drug Name
ASENAPINE MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2020-12-10
Active Ingredient
ASENAPINE MALEATE
Application Number
206098
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2020-12-10
Regulatory Status
RX
Drug Name
ASENAPINE MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-12-10
Active Ingredient
ASENAPINE MALEATE
Application Number
206098
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-12-10
Regulatory Status
RX
Drug Name
ASENAPINE MALEATE
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2021-07-19
Active Ingredient
ASENAPINE MALEATE
Application Number
206098
Product Number
3
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2021-07-19
Regulatory Status
RX
Drug Name
AZELASTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-03-20
Active Ingredient
AZELASTINE HYDROCHLORIDE
Application Number
209620
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-03-20
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2020-01-28
Active Ingredient
AZITHROMYCIN
Application Number
211791
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2020-01-28
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2020-01-28
Active Ingredient
AZITHROMYCIN
Application Number
211792
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2020-01-28
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2020-01-27
Active Ingredient
AZITHROMYCIN
Application Number
211793
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2020-01-27
Regulatory Status
RX
Drug Name
BEPOTASTINE BESILATE
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2023-04-05
Active Ingredient
BEPOTASTINE BESILATE
Application Number
214588
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2023-04-05
Regulatory Status
RX
Drug Name
BETAMETHASONE VALERATE
Product Number
1
Dosage Form
-
Strength
0.12%
Approval Date
2024-08-22
Active Ingredient
BETAMETHASONE VALERATE
Application Number
215832
Product Number
1
Dosage Form
-
Strength
0.12%
Approval Date
2024-08-22
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2019-04-12
Active Ingredient
BIMATOPROST
Application Number
210263
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2019-04-12
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2020-01-21
Active Ingredient
BIMATOPROST
Application Number
210515
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2020-01-21
Regulatory Status
RX
Drug Name
BINIMETINIB
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
-
Active Ingredient
BINIMETINIB
Application Number
217678
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
BISOPROLOL FUMARATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-01-11
Active Ingredient
BISOPROLOL FUMARATE
Application Number
204891
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-01-11
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2017-01-11
Active Ingredient
BISOPROLOL FUMARATE
Application Number
204891
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2017-01-11
Regulatory Status
RX
Drug Name
BOSENTAN
Product Number
1
Dosage Form
-
Strength
62.5MG
Approval Date
2020-01-23
Active Ingredient
BOSENTAN
Application Number
211461
Product Number
1
Dosage Form
-
Strength
62.5MG
Approval Date
2020-01-23
Regulatory Status
Discontinued
Drug Name
BOSENTAN
Product Number
2
Dosage Form
-
Strength
125MG
Approval Date
2020-01-23
Active Ingredient
BOSENTAN
Application Number
211461
Product Number
2
Dosage Form
-
Strength
125MG
Approval Date
2020-01-23
Regulatory Status
Discontinued
Drug Name
BOSUTINIB MONOHYDRATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-05-23
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
209543
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-05-23
Regulatory Status
RX
Drug Name
BOSUTINIB MONOHYDRATE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2025-05-23
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
209543
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2025-05-23
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2025-01-13
Active Ingredient
BREXPIPRAZOLE
Application Number
213683
Product Number
1
Dosage Form
-
Strength
0.25MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2025-01-13
Active Ingredient
BREXPIPRAZOLE
Application Number
213683
Product Number
2
Dosage Form
-
Strength
0.5MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2025-01-13
Active Ingredient
BREXPIPRAZOLE
Application Number
213683
Product Number
3
Dosage Form
-
Strength
1MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2025-01-13
Active Ingredient
BREXPIPRAZOLE
Application Number
213683
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2025-01-13
Active Ingredient
BREXPIPRAZOLE
Application Number
213683
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
BREXPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2025-01-13
Active Ingredient
BREXPIPRAZOLE
Application Number
213683
Product Number
6
Dosage Form
-
Strength
4MG
Approval Date
2025-01-13
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.15%
Approval Date
2023-03-29
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
215225
Product Number
1
Dosage Form
-
Strength
0.15%
Approval Date
2023-03-29
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2023-08-01
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
216909
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2023-08-01
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2023-08-25
Active Ingredient
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
Application Number
215230
Product Number
1
Dosage Form
-
Strength
0.2%;EQ 0.5% BASE
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2019-06-21
Active Ingredient
BROMFENAC SODIUM
Application Number
210560
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2019-06-21
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.07% ACID
Approval Date
2024-07-08
Active Ingredient
BROMFENAC SODIUM
Application Number
214340
Product Number
1
Dosage Form
-
Strength
EQ 0.07% ACID
Approval Date
2024-07-08
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2018-06-08
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
203013
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2018-06-08
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2018-06-08
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
203013
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2018-06-08
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
1
Dosage Form
-
Strength
32MG
Approval Date
2017-06-20
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
209119
Product Number
1
Dosage Form
-
Strength
32MG
Approval Date
2017-06-20
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-04
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
210302
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-04
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-04
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
210302
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-04
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2018-12-04
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
210302
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2018-12-04
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2025-04-16
Active Ingredient
CARBAMAZEPINE
Application Number
216623
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2025-04-16
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-07-25
Active Ingredient
CARBAMAZEPINE
Application Number
219939
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-07-25
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-07-25
Active Ingredient
CARBAMAZEPINE
Application Number
219939
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-07-25
Regulatory Status
RX
Drug Name
CARBAMAZEPINE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2025-07-25
Active Ingredient
CARBAMAZEPINE
Application Number
219939
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2025-07-25
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
1
Dosage Form
-
Strength
25MG;100MG
Approval Date
2019-06-05
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
210341
Product Number
1
Dosage Form
-
Strength
25MG;100MG
Approval Date
2019-06-05
Regulatory Status
RX
Drug Name
CARBIDOPA AND LEVODOPA
Product Number
2
Dosage Form
-
Strength
50MG;200MG
Approval Date
2019-06-05
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
210341
Product Number
2
Dosage Form
-
Strength
50MG;200MG
Approval Date
2019-06-05
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
1
Dosage Form
-
Strength
12.5MG;200MG;50MG
Approval Date
2026-02-05
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
218535
Product Number
1
Dosage Form
-
Strength
12.5MG;200MG;50MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
2
Dosage Form
-
Strength
18.75MG;200MG;75MG
Approval Date
2026-02-05
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
218535
Product Number
2
Dosage Form
-
Strength
18.75MG;200MG;75MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
3
Dosage Form
-
Strength
25MG;200MG;100MG
Approval Date
2026-02-05
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
218535
Product Number
3
Dosage Form
-
Strength
25MG;200MG;100MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
4
Dosage Form
-
Strength
31.25MG;200MG;125MG
Approval Date
2026-02-05
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
218535
Product Number
4
Dosage Form
-
Strength
31.25MG;200MG;125MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
5
Dosage Form
-
Strength
37.5MG;200MG;150MG
Approval Date
2026-02-05
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
218535
Product Number
5
Dosage Form
-
Strength
37.5MG;200MG;150MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
6
Dosage Form
-
Strength
50MG;200MG;200MG
Approval Date
2026-02-05
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
218535
Product Number
6
Dosage Form
-
Strength
50MG;200MG;200MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
CARBOPROST TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2023-06-15
Active Ingredient
CARBOPROST TROMETHAMINE
Application Number
217198
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2023-06-15
Regulatory Status
RX
Drug Name
CARMUSTINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-10-20
Active Ingredient
CARMUSTINE
Application Number
215730
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-10-20
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2015-08-21
Active Ingredient
CELECOXIB
Application Number
204519
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2015-08-21
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-08-21
Active Ingredient
CELECOXIB
Application Number
204519
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-08-21
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2015-08-21
Active Ingredient
CELECOXIB
Application Number
204519
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2015-08-21
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2015-08-21
Active Ingredient
CELECOXIB
Application Number
204519
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2015-08-21
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2023-09-15
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Application Number
216969
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2023-09-15
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-07-18
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
217350
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-07-18
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-07-18
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
217350
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-07-18
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2023-07-18
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
217350
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2023-07-18
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2023-07-18
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
217350
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2023-07-18
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-07-18
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
217350
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-07-18
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-08-26
Active Ingredient
CHLORTHALIDONE
Application Number
216262
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-08-26
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-08-26
Active Ingredient
CHLORTHALIDONE
Application Number
216262
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-08-26
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2022-01-31
Active Ingredient
CLARITHROMYCIN
Application Number
210459
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2022-01-31
Regulatory Status
RX
Drug Name
CLARITHROMYCIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2022-01-31
Active Ingredient
CLARITHROMYCIN
Application Number
210459
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2022-01-31
Regulatory Status
RX
Drug Name
CLINDAMYCIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
2024-04-02
Active Ingredient
CLINDAMYCIN PHOSPHATE
Application Number
212466
Product Number
1
Dosage Form
-
Strength
EQ 1% BASE
Approval Date
2024-04-02
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-02
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
211191
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-02
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-03-04
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
211800
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-03-04
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-21
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
212881
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-21
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-05-18
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
213290
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-05-18
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-01-27
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
213291
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-01-27
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-04-21
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
215838
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-04-21
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2021-08-04
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
211822
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2021-08-04
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2021-08-04
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
211822
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2021-08-04
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2021-08-04
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
211822
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2021-08-04
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2019-06-28
Active Ingredient
CLONAZEPAM
Application Number
211033
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2019-06-28
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2019-06-28
Active Ingredient
CLONAZEPAM
Application Number
211033
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2019-06-28
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2019-06-28
Active Ingredient
CLONAZEPAM
Application Number
211033
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2019-06-28
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2019-06-28
Active Ingredient
CLONAZEPAM
Application Number
211033
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2019-06-28
Regulatory Status
RX
Drug Name
CLONAZEPAM
Product Number
5
Dosage Form
-
Strength
2MG
Approval Date
2019-06-28
Active Ingredient
CLONAZEPAM
Application Number
211033
Product Number
5
Dosage Form
-
Strength
2MG
Approval Date
2019-06-28
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
2011-12-06
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
91368
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
2011-12-06
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.2MG
Approval Date
2011-12-06
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
91368
Product Number
2
Dosage Form
-
Strength
0.2MG
Approval Date
2011-12-06
Regulatory Status
RX
Drug Name
CLONIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.3MG
Approval Date
2011-12-06
Active Ingredient
CLONIDINE HYDROCHLORIDE
Application Number
91368
Product Number
3
Dosage Form
-
Strength
0.3MG
Approval Date
2011-12-06
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-11-10
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
215892
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-11-10
Regulatory Status
RX
Drug Name
CYCLOPHOSPHAMIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-11-10
Active Ingredient
CYCLOPHOSPHAMIDE
Application Number
215892
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-11-10
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
-
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
208046
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-06-14
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
215233
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-06-14
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-06-14
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
215233
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-06-14
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 110MG BASE
Approval Date
2024-08-12
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
215233
Product Number
3
Dosage Form
-
Strength
EQ 110MG BASE
Approval Date
2024-08-12
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211560
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211560
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2026-06-25
Active Ingredient
DAPSONE
Application Number
213414
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2023-10-27
Active Ingredient
DAPSONE
Application Number
215718
Product Number
1
Dosage Form
-
Strength
7.5%
Approval Date
2023-10-27
Regulatory Status
RX
Drug Name
DARIFENACIN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2017-12-08
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
207681
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2017-12-08
Regulatory Status
RX
Drug Name
DARIFENACIN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2017-12-08
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
207681
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2017-12-08
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-11-06
Active Ingredient
DASATINIB
Application Number
216261
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-11-06
Active Ingredient
DASATINIB
Application Number
216261
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
3
Dosage Form
-
Strength
70MG
Approval Date
2025-11-06
Active Ingredient
DASATINIB
Application Number
216261
Product Number
3
Dosage Form
-
Strength
70MG
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2025-11-06
Active Ingredient
DASATINIB
Application Number
216261
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-11-06
Active Ingredient
DASATINIB
Application Number
216261
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
6
Dosage Form
-
Strength
140MG
Approval Date
2025-11-06
Active Ingredient
DASATINIB
Application Number
216261
Product Number
6
Dosage Form
-
Strength
140MG
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
210060
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
210060
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
210060
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
211824
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
211824
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
2020-06-15
Active Ingredient
DEFERASIROX
Application Number
211824
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
2020-06-15
Regulatory Status
RX
Drug Name
DESIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-07-07
Active Ingredient
DESIPRAMINE HYDROCHLORIDE
Application Number
209785
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-07-07
Regulatory Status
RX
Drug Name
DESIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2021-07-07
Active Ingredient
DESIPRAMINE HYDROCHLORIDE
Application Number
209785
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2021-07-07
Regulatory Status
RX
Drug Name
DESIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2021-07-07
Active Ingredient
DESIPRAMINE HYDROCHLORIDE
Application Number
209785
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2021-07-07
Regulatory Status
RX
Drug Name
DESIPRAMINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2021-07-07
Active Ingredient
DESIPRAMINE HYDROCHLORIDE
Application Number
209785
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2021-07-07
Regulatory Status
RX
Drug Name
DESIPRAMINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2021-07-07
Active Ingredient
DESIPRAMINE HYDROCHLORIDE
Application Number
209785
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2021-07-07
Regulatory Status
RX
Drug Name
DESIPRAMINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
150MG
Approval Date
2021-07-07
Active Ingredient
DESIPRAMINE HYDROCHLORIDE
Application Number
209785
Product Number
6
Dosage Form
-
Strength
150MG
Approval Date
2021-07-07
Regulatory Status
RX
Drug Name
DESONIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-23
Active Ingredient
DESONIDE
Application Number
212473
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2019-10-23
Regulatory Status
RX
Drug Name
DESONIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-08-24
Active Ingredient
DESONIDE
Application Number
213632
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2020-08-24
Regulatory Status
RX
Drug Name
DESONIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-12-08
Active Ingredient
DESONIDE
Application Number
214396
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2022-12-08
Regulatory Status
RX
Drug Name
DESVENLAFAXINE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2013-03-04
Active Ingredient
DESVENLAFAXINE
Application Number
204150
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2013-03-04
Regulatory Status
RX
Drug Name
DESVENLAFAXINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2013-03-04
Active Ingredient
DESVENLAFAXINE
Application Number
204150
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2013-03-04
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2015-06-29
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204003
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2015-06-29
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2015-06-29
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204003
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2015-06-29
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-09-14
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204003
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2018-09-14
Regulatory Status
RX
Drug Name
DEXLANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2025-11-12
Active Ingredient
DEXLANSOPRAZOLE
Application Number
219115
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2025-11-12
Regulatory Status
RX
Drug Name
DEXLANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-11-12
Active Ingredient
DEXLANSOPRAZOLE
Application Number
219115
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-11-12
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
10MG/2ML (5MG/ML)
Approval Date
2024-04-25
Active Ingredient
DIAZEPAM
Application Number
218450
Product Number
1
Dosage Form
-
Strength
10MG/2ML (5MG/ML)
Approval Date
2024-04-25
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
3%
Approval Date
2022-07-27
Active Ingredient
DICLOFENAC SODIUM
Application Number
212351
Product Number
1
Dosage Form
-
Strength
3%
Approval Date
2022-07-27
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
2022-11-29
Active Ingredient
DICLOFENAC SODIUM
Application Number
212506
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
2022-11-29
Regulatory Status
RX
Drug Name
DIFLUPREDNATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2026-01-26
Active Ingredient
DIFLUPREDNATE
Application Number
213774
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2026-01-26
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2024-11-08
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
216968
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2024-11-08
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
216968
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
2024-11-08
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
216968
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2024-11-08
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
216968
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
360MG
Approval Date
2024-11-08
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
216968
Product Number
5
Dosage Form
-
Strength
360MG
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2025-11-14
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
217633
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2025-11-14
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-11-14
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
217633
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-11-14
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2025-11-14
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
217633
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2025-11-14
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
120MG
Approval Date
2025-11-14
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
217633
Product Number
4
Dosage Form
-
Strength
120MG
Approval Date
2025-11-14
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2024-10-18
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218587
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2024-10-18
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2024-10-18
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218587
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2024-10-18
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
2024-10-18
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218587
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
2024-10-18
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2024-12-19
Active Ingredient
DIVALPROEX SODIUM
Application Number
218793
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2024-12-19
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2023-02-28
Active Ingredient
DOCETAXEL
Application Number
215744
Product Number
1
Dosage Form
-
Strength
20MG/2ML (10MG/ML)
Approval Date
2023-02-28
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2023-02-28
Active Ingredient
DOCETAXEL
Application Number
215744
Product Number
2
Dosage Form
-
Strength
80MG/8ML (10MG/ML)
Approval Date
2023-02-28
Regulatory Status
RX
Drug Name
DOCETAXEL
Product Number
3
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2023-02-28
Active Ingredient
DOCETAXEL
Application Number
215744
Product Number
3
Dosage Form
-
Strength
160MG/16ML (10MG/ML)
Approval Date
2023-02-28
Regulatory Status
RX
Drug Name
DOCOSANOL
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2022-05-03
Active Ingredient
DOCOSANOL
Application Number
215839
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2022-05-03
Regulatory Status
OTC
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2013-02-25
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
201724
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2013-02-25
Regulatory Status
RX
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2013-02-25
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
201724
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2013-02-25
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2019-08-09
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE
Application Number
212639
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2019-08-09
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2021-05-04
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
213099
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2021-05-04
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2021-04-21
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215076
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2021-04-21
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-04-21
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215076
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-04-21
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-04-21
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215076
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-04-21
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2021-04-21
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215076
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2021-04-21
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2021-04-21
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215076
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2021-04-21
Regulatory Status
RX
Drug Name
DOXERCALCIFEROL
Product Number
1
Dosage Form
-
Strength
4MCG/2ML (2MCG/ML)
Approval Date
2023-06-15
Active Ingredient
DOXERCALCIFEROL
Application Number
215810
Product Number
1
Dosage Form
-
Strength
4MCG/2ML (2MCG/ML)
Approval Date
2023-06-15
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Product Number
1
Dosage Form
-
Strength
20MG/10ML (2MG/ML)
Approval Date
2025-06-27
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
219199
Product Number
1
Dosage Form
-
Strength
20MG/10ML (2MG/ML)
Approval Date
2025-06-27
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Product Number
2
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2025-06-27
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
219199
Product Number
2
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2025-06-27
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-07-28
Active Ingredient
DOXYCYCLINE
Application Number
209165
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-07-28
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-07-28
Active Ingredient
DOXYCYCLINE
Application Number
209165
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2017-07-28
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2024-06-27
Active Ingredient
DOXYCYCLINE
Application Number
217674
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2024-06-27
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2018-06-13
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
210527
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2018-06-13
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-06-13
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
210527
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2018-06-13
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-05-14
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
210536
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2020-05-14
Regulatory Status
Discontinued
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-09-14
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
210536
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2021-09-14
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-03-03
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
210537
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-03-03
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-06-30
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
211744
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-06-30
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2020-06-30
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
211744
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2020-06-30
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2022-01-03
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
213075
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2022-01-03
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2022-01-03
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
213075
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2022-01-03
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2022-01-03
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
213075
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2022-01-03
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2022-01-03
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
213075
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2022-01-03
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2014-06-09
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
202949
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2014-06-09
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2014-06-09
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
202949
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2014-06-09
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2014-06-09
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
202949
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2014-06-09
Regulatory Status
RX
Drug Name
EFINACONAZOLE
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2026-02-23
Active Ingredient
EFINACONAZOLE
Application Number
212027
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2026-02-23
Regulatory Status
RX
Drug Name
ENTACAPONE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2022-01-04
Active Ingredient
ENTACAPONE
Application Number
212601
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2022-01-04
Regulatory Status
RX
Drug Name
ERLOTINIB HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-07-08
Active Ingredient
ERLOTINIB HYDROCHLORIDE
Application Number
214719
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-07-08
Regulatory Status
RX
Drug Name
ERLOTINIB HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2021-07-08
Active Ingredient
ERLOTINIB HYDROCHLORIDE
Application Number
214719
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2021-07-08
Regulatory Status
RX
Drug Name
ERLOTINIB HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2021-07-08
Active Ingredient
ERLOTINIB HYDROCHLORIDE
Application Number
214719
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2021-07-08
Regulatory Status
RX
Drug Name
ERYTHROMYCIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2023-08-24
Active Ingredient
ERYTHROMYCIN
Application Number
215661
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2023-08-24
Regulatory Status
RX
Drug Name
ERYTHROMYCIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2023-08-24
Active Ingredient
ERYTHROMYCIN
Application Number
215661
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2023-08-24
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2009-05-22
Active Ingredient
FAMOTIDINE
Application Number
78916
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2009-05-22
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2009-05-22
Active Ingredient
FAMOTIDINE
Application Number
78916
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2009-05-22
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2019-07-01
Active Ingredient
FEBUXOSTAT
Application Number
205421
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2019-07-01
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2019-07-01
Active Ingredient
FEBUXOSTAT
Application Number
205421
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2019-07-01
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2019-08-09
Active Ingredient
FENOFIBRATE
Application Number
210476
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2019-08-09
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2019-08-09
Active Ingredient
FENOFIBRATE
Application Number
210476
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2019-08-09
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2020-01-17
Active Ingredient
FENOFIBRATE
Application Number
213252
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2020-01-17
Regulatory Status
Discontinued
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2020-01-17
Active Ingredient
FENOFIBRATE
Application Number
213252
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2020-01-17
Regulatory Status
Discontinued
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2020-10-19
Active Ingredient
FENOFIBRATE
Application Number
213842
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2020-10-19
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2020-10-19
Active Ingredient
FENOFIBRATE
Application Number
213842
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2020-10-19
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2020-10-19
Active Ingredient
FENOFIBRATE
Application Number
213842
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2020-10-19
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2017-05-12
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
208705
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2017-05-12
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
208705
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2017-05-12
Regulatory Status
RX
Drug Name
FESOTERODINE FUMARATE
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2023-01-04
Active Ingredient
FESOTERODINE FUMARATE
Application Number
204973
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2023-01-04
Regulatory Status
RX
Drug Name
FESOTERODINE FUMARATE
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2023-01-04
Active Ingredient
FESOTERODINE FUMARATE
Application Number
204973
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2023-01-04
Regulatory Status
RX
Drug Name
FINGOLIMOD HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2026-04-24
Active Ingredient
FINGOLIMOD HYDROCHLORIDE
Application Number
207974
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2026-04-24
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
1
Dosage Form
-
Strength
2.5GM/50ML (50MG/ML)
Approval Date
2023-03-03
Active Ingredient
FLUOROURACIL
Application Number
217295
Product Number
1
Dosage Form
-
Strength
2.5GM/50ML (50MG/ML)
Approval Date
2023-03-03
Regulatory Status
RX
Drug Name
FLUOROURACIL
Product Number
1
Dosage Form
-
Strength
5GM/100ML (50MG/ML)
Approval Date
2023-10-18
Active Ingredient
FLUOROURACIL
Application Number
217676
Product Number
1
Dosage Form
-
Strength
5GM/100ML (50MG/ML)
Approval Date
2023-10-18
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2009-03-19
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
90223
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2009-03-19
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2009-03-19
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
90223
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2009-03-19
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2009-03-19
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
90223
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2009-03-19
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-04-05
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
208698
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-04-05
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-04-05
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
208698
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-04-05
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2024-07-23
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218173
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2024-07-23
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2024-07-23
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218173
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2024-07-23
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2024-07-23
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218173
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2024-07-23
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2024-07-23
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
218173
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2024-07-23
Regulatory Status
RX
Drug Name
FORMOTEROL FUMARATE
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2021-11-22
Active Ingredient
FORMOTEROL FUMARATE
Application Number
215078
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2021-11-22
Regulatory Status
RX
Drug Name
FULVESTRANT
Product Number
1
Dosage Form
-
Strength
250MG/5ML (50MG/ML)
Approval Date
2022-12-22
Active Ingredient
FULVESTRANT
Application Number
215077
Product Number
1
Dosage Form
-
Strength
250MG/5ML (50MG/ML)
Approval Date
2022-12-22
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2018-11-30
Active Ingredient
GLYCOPYRROLATE
Application Number
203657
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2018-11-30
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2018-11-30
Active Ingredient
GLYCOPYRROLATE
Application Number
203657
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2018-11-30
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2022-10-26
Active Ingredient
GLYCOPYRROLATE
Application Number
214635
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2022-10-26
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-08-07
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
217269
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-08-07
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
217269
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2023-08-07
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
217269
Product Number
3
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
GUANFACINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2023-08-07
Active Ingredient
GUANFACINE HYDROCHLORIDE
Application Number
217269
Product Number
4
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2023-08-07
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2026-06-04
Active Ingredient
HALOPERIDOL
Application Number
214470
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2026-06-04
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2026-06-04
Active Ingredient
HALOPERIDOL
Application Number
214470
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2026-06-04
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2026-06-04
Active Ingredient
HALOPERIDOL
Application Number
214470
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2026-06-04
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2026-06-04
Active Ingredient
HALOPERIDOL
Application Number
214470
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2026-06-04
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2026-06-04
Active Ingredient
HALOPERIDOL
Application Number
214470
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2026-06-04
Regulatory Status
RX
Drug Name
HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2010-11-30
Active Ingredient
HYDROCHLOROTHIAZIDE
Application Number
200645
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2010-11-30
Regulatory Status
Discontinued
Drug Name
ICATIBANT ACETATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2024-06-14
Active Ingredient
ICATIBANT ACETATE
Application Number
213773
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2024-06-14
Regulatory Status
RX
Drug Name
ILOPERIDONE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
-
Active Ingredient
ILOPERIDONE
Application Number
207409
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ILOPERIDONE
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
-
Active Ingredient
ILOPERIDONE
Application Number
207409
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ILOPERIDONE
Product Number
4
Dosage Form
-
Strength
6MG
Approval Date
-
Active Ingredient
ILOPERIDONE
Application Number
207409
Product Number
4
Dosage Form
-
Strength
6MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ILOPERIDONE
Product Number
5
Dosage Form
-
Strength
8MG
Approval Date
-
Active Ingredient
ILOPERIDONE
Application Number
207409
Product Number
5
Dosage Form
-
Strength
8MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ILOPERIDONE
Product Number
6
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
ILOPERIDONE
Application Number
207409
Product Number
6
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
IRBESARTAN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-10-15
Active Ingredient
IRBESARTAN
Application Number
91236
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-10-15
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-10-15
Active Ingredient
IRBESARTAN
Application Number
91236
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-10-15
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-10-15
Active Ingredient
IRBESARTAN
Application Number
91236
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-10-15
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2012-10-15
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
91370
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2012-10-15
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2012-10-15
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
91370
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2012-10-15
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;300MG
Approval Date
2016-10-12
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
91370
Product Number
3
Dosage Form
-
Strength
25MG;300MG
Approval Date
2016-10-12
Regulatory Status
RX
Drug Name
ITRACONAZOLE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2016-12-13
Active Ingredient
ITRACONAZOLE
Application Number
206741
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2016-12-13
Regulatory Status
RX
Drug Name
IVABRADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-11-08
Active Ingredient
IVABRADINE HYDROCHLORIDE
Application Number
215238
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
IVABRADINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2024-11-08
Active Ingredient
IVABRADINE HYDROCHLORIDE
Application Number
215238
Product Number
2
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2024-11-08
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2022-11-02
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
214456
Product Number
1
Dosage Form
-
Strength
15MG/ML
Approval Date
2022-11-02
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2022-11-02
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
214456
Product Number
2
Dosage Form
-
Strength
30MG/ML
Approval Date
2022-11-02
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204974
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204974
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204974
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204974
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2011-01-13
Active Ingredient
LAMOTRIGINE
Application Number
90607
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2011-01-13
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2011-01-13
Active Ingredient
LAMOTRIGINE
Application Number
90607
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2011-01-13
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2011-01-13
Active Ingredient
LAMOTRIGINE
Application Number
90607
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2011-01-13
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2011-01-13
Active Ingredient
LAMOTRIGINE
Application Number
90607
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2011-01-13
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2014-06-12
Active Ingredient
LAMOTRIGINE
Application Number
201168
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2014-06-12
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2014-06-12
Active Ingredient
LAMOTRIGINE
Application Number
201168
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2014-06-12
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-10-01
Active Ingredient
LAMOTRIGINE
Application Number
211821
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2024-10-01
Active Ingredient
LAMOTRIGINE
Application Number
211821
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2024-10-01
Active Ingredient
LAMOTRIGINE
Application Number
211821
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-02-25
Active Ingredient
LAMOTRIGINE
Application Number
217278
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2026-02-25
Active Ingredient
LAMOTRIGINE
Application Number
217278
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2026-02-25
Active Ingredient
LAMOTRIGINE
Application Number
217278
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
LAMOTRIGINE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2026-02-25
Active Ingredient
LAMOTRIGINE
Application Number
217278
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2026-02-25
Regulatory Status
RX
Drug Name
LAROTRECTINIB
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
LAROTRECTINIB
Application Number
220639
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LEFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-11-21
Active Ingredient
LEFLUNOMIDE
Application Number
91369
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2011-11-21
Regulatory Status
RX
Drug Name
LEFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2011-11-21
Active Ingredient
LEFLUNOMIDE
Application Number
91369
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2011-11-21
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2013-05-09
Active Ingredient
LEVETIRACETAM
Application Number
203067
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2013-05-09
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
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
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
11
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
11
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
LEVOTHYROXINE SODIUM
Product Number
12
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
216370
Product Number
12
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2026-05-20
Regulatory Status
RX
Drug Name
LIDOCAINE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2018-11-23
Active Ingredient
LIDOCAINE
Application Number
211469
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
LIDOCAINE AND PRILOCAINE
Product Number
1
Dosage Form
-
Strength
2.5%;2.5%
Approval Date
2022-04-08
Active Ingredient
LIDOCAINE; PRILOCAINE
Application Number
213923
Product Number
1
Dosage Form
-
Strength
2.5%;2.5%
Approval Date
2022-04-08
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2015-12-21
Active Ingredient
LINEZOLID
Application Number
205233
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2015-12-21
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2009-01-12
Active Ingredient
LITHIUM CARBONATE
Application Number
79159
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2009-01-12
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2009-01-12
Active Ingredient
LITHIUM CARBONATE
Application Number
79159
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2009-01-12
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2009-01-12
Active Ingredient
LITHIUM CARBONATE
Application Number
79159
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2009-01-12
Regulatory Status
RX
Drug Name
LITHIUM CARBONATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2015-06-10
Active Ingredient
LITHIUM CARBONATE
Application Number
204445
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2015-06-10
Regulatory Status
Discontinued
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90428
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90428
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
90428
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2012-02-17
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91617
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2012-02-17
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2012-02-17
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91617
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2012-02-17
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2012-02-17
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
91617
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2012-02-17
Regulatory Status
RX
Drug Name
LOTEPREDNOL ETABONATE AND TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
0.5%;0.3%
Approval Date
2025-12-10
Active Ingredient
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Application Number
217597
Product Number
1
Dosage Form
-
Strength
0.5%;0.3%
Approval Date
2025-12-10
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2021-05-13
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
213248
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2021-05-13
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2021-05-13
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
213248
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2021-05-13
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2021-05-13
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
213248
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2021-05-13
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2021-05-13
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
213248
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2021-05-13
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2021-05-13
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
213248
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2021-05-13
Regulatory Status
RX
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-08-18
Active Ingredient
MACITENTAN
Application Number
211128
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-08-18
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-10-13
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
200891
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-10-13
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
200891
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Regulatory Status
RX
Drug Name
MEPROBAMATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2009-02-18
Active Ingredient
MEPROBAMATE
Application Number
90122
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2009-02-18
Regulatory Status
RX
Drug Name
MEPROBAMATE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2009-02-18
Active Ingredient
MEPROBAMATE
Application Number
90122
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2009-02-18
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2022-10-28
Active Ingredient
MESALAMINE
Application Number
216967
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2022-10-28
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2024-06-03
Active Ingredient
METHOTREXATE SODIUM
Application Number
217552
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2024-06-03
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date
2026-04-15
Active Ingredient
METHOTREXATE SODIUM
Application Number
220225
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/2ML (EQ 25MG BASE/ML)
Approval Date
2026-04-15
Regulatory Status
RX
Drug Name
METHOTREXATE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date
2026-04-15
Active Ingredient
METHOTREXATE SODIUM
Application Number
220225
Product Number
2
Dosage Form
-
Strength
EQ 1GM BASE/40ML (EQ 25MG BASE/ML)
Approval Date
2026-04-15
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-12-02
Active Ingredient
METOLAZONE
Application Number
213251
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2020-12-02
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-12-02
Active Ingredient
METOLAZONE
Application Number
213251
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2020-12-02
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2020-12-02
Active Ingredient
METOLAZONE
Application Number
213251
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2020-12-02
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2013-05-28
Active Ingredient
METOPROLOL TARTRATE
Application Number
202871
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2013-05-28
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2013-05-28
Active Ingredient
METOPROLOL TARTRATE
Application Number
202871
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2013-05-28
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2013-05-28
Active Ingredient
METOPROLOL TARTRATE
Application Number
202871
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2013-05-28
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;50MG
Approval Date
2013-11-06
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
202870
Product Number
1
Dosage Form
-
Strength
25MG;50MG
Approval Date
2013-11-06
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2013-11-06
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
202870
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
2013-11-06
Regulatory Status
RX
Drug Name
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
50MG;100MG
Approval Date
2013-11-06
Active Ingredient
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
Application Number
202870
Product Number
3
Dosage Form
-
Strength
50MG;100MG
Approval Date
2013-11-06
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2009-06-23
Active Ingredient
METRONIDAZOLE
Application Number
79065
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2009-06-23
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-03-13
Active Ingredient
METRONIDAZOLE
Application Number
79067
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-03-13
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-03-13
Active Ingredient
METRONIDAZOLE
Application Number
79067
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-03-13
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2010-05-05
Active Ingredient
METRONIDAZOLE
Application Number
90222
Product Number
1
Dosage Form
-
Strength
750MG
Approval Date
2010-05-05
Regulatory Status
Discontinued
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2017-06-20
Active Ingredient
METRONIDAZOLE
Application Number
208681
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2017-06-20
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2017-06-20
Active Ingredient
METRONIDAZOLE
Application Number
208681
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2017-06-20
Regulatory Status
RX
Drug Name
METRONIDAZOLE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2021-09-03
Active Ingredient
METRONIDAZOLE
Application Number
212646
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2021-09-03
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2021-01-21
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
214734
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2021-01-21
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2021-01-21
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
214734
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2021-01-21
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2021-01-21
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
214734
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2021-01-21
Regulatory Status
RX
Drug Name
MODAFINIL
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-10-18
Active Ingredient
MODAFINIL
Application Number
202700
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2012-10-18
Regulatory Status
RX
Drug Name
MODAFINIL
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2012-10-18
Active Ingredient
MODAFINIL
Application Number
202700
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2012-10-18
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2019-02-13
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
209469
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2019-02-13
Regulatory Status
RX
Drug Name
MUPIROCIN
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2021-11-16
Active Ingredient
MUPIROCIN CALCIUM
Application Number
213053
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2021-11-16
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-06-02
Active Ingredient
NADOLOL
Application Number
211763
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-06-02
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2023-06-02
Active Ingredient
NADOLOL
Application Number
211763
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2023-06-02
Regulatory Status
RX
Drug Name
NADOLOL
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2023-06-02
Active Ingredient
NADOLOL
Application Number
211763
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2023-06-02
Regulatory Status
RX
Drug Name
NELARABINE
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2024-08-01
Active Ingredient
NELARABINE
Application Number
218554
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2024-08-01
Regulatory Status
RX
Drug Name
NIFEDIPINE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2022-11-18
Active Ingredient
NIFEDIPINE
Application Number
216896
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
NIFEDIPINE
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2022-11-18
Active Ingredient
NIFEDIPINE
Application Number
216896
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
NIFEDIPINE
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2022-11-18
Active Ingredient
NIFEDIPINE
Application Number
216896
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2021-06-25
Active Ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Application Number
211935
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2021-06-25
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2021-06-25
Active Ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Application Number
211935
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2021-06-25
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2021-06-25
Active Ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Application Number
211935
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2021-06-25
Regulatory Status
RX
Drug Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2021-03-31
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
214090
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2021-03-31
Regulatory Status
RX
Drug Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2022-03-04
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
214186
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2022-03-04
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
203012
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
203012
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-04-24
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
203012
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2017-04-24
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
204233
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2017-04-24
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
204233
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2017-04-24
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
204233
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2017-04-24
Regulatory Status
RX
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE
Approval Date
2019-04-29
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
209420
Product Number
1
Dosage Form
-
Strength
EQ 0.2% BASE
Approval Date
2019-04-29
Regulatory Status
OTC
Drug Name
OLOPATADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
2018-12-07
Active Ingredient
OLOPATADINE HYDROCHLORIDE
Application Number
209919
Product Number
1
Dosage Form
-
Strength
EQ 0.1% BASE
Approval Date
2018-12-07
Regulatory Status
OTC
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2019-06-24
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
211823
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2019-06-24
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2019-06-24
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
211823
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2019-06-24
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2019-06-24
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
211823
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2019-06-24
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2026-06-25
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
218307
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2026-06-25
Regulatory Status
RX
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2022-10-20
Active Ingredient
PACLITAXEL
Application Number
216874
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2022-10-20
Regulatory Status
RX
Drug Name
PALIPERIDONE
Product Number
1
Dosage Form
-
Strength
1.5MG
Approval Date
2024-09-26
Active Ingredient
PALIPERIDONE
Application Number
218330
Product Number
1
Dosage Form
-
Strength
1.5MG
Approval Date
2024-09-26
Regulatory Status
RX
Drug Name
PALIPERIDONE
Product Number
2
Dosage Form
-
Strength
3MG
Approval Date
2024-09-26
Active Ingredient
PALIPERIDONE
Application Number
218330
Product Number
2
Dosage Form
-
Strength
3MG
Approval Date
2024-09-26
Regulatory Status
RX
Drug Name
PALIPERIDONE
Product Number
3
Dosage Form
-
Strength
6MG
Approval Date
2024-09-26
Active Ingredient
PALIPERIDONE
Application Number
218330
Product Number
3
Dosage Form
-
Strength
6MG
Approval Date
2024-09-26
Regulatory Status
RX
Drug Name
PALIPERIDONE
Product Number
4
Dosage Form
-
Strength
9MG
Approval Date
2024-09-26
Active Ingredient
PALIPERIDONE
Application Number
218330
Product Number
4
Dosage Form
-
Strength
9MG
Approval Date
2024-09-26
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2025-03-31
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
219230
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE/VIAL
Approval Date
2025-03-31
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2025-09-24
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
217280
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2025-09-24
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2025-09-24
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
217280
Product Number
2
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2025-09-24
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2026-03-26
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
217280
Product Number
3
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2026-03-26
Regulatory Status
RX
Drug Name
PHYTONADIONE
Product Number
1
Dosage Form
-
Strength
1MG/0.5ML
Approval Date
2025-09-08
Active Ingredient
PHYTONADIONE
Application Number
216444
Product Number
1
Dosage Form
-
Strength
1MG/0.5ML
Approval Date
2025-09-08
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-05-20
Active Ingredient
PIRFENIDONE
Application Number
212708
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-05-20
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-05-20
Active Ingredient
PIRFENIDONE
Application Number
212708
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-05-20
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
78894
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2010-10-08
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
78894
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2010-10-08
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
78894
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2010-10-08
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
78894
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2010-10-08
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
2010-10-08
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
78894
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
2010-10-08
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.375MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
1
Dosage Form
-
Strength
0.375MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.75MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
2
Dosage Form
-
Strength
0.75MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
2.25MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
4
Dosage Form
-
Strength
2.25MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
3.75MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
6
Dosage Form
-
Strength
3.75MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
4.5MG
Approval Date
2019-01-02
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
204518
Product Number
7
Dosage Form
-
Strength
4.5MG
Approval Date
2019-01-02
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-03-06
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
217268
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-03-06
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
217268
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-03-06
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
217268
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-03-06
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
203459
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-07-27
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
219234
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-07-27
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2026-07-27
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
219234
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2026-07-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2014-10-28
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203390
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2014-10-28
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2014-10-28
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203390
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2014-10-28
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2014-10-28
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203390
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2014-10-28
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2014-10-28
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203390
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2014-10-28
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2014-10-28
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203390
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2014-10-28
Regulatory Status
Discontinued
Drug Name
QUETIAPINE FUMARATE
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2014-10-28
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203390
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2014-10-28
Regulatory Status
Discontinued
Drug Name
RIBOCICLIB
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Active Ingredient
RIBOCICLIB
Application Number
215677
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-05-14
Active Ingredient
RIVAROXABAN
Application Number
210301
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-05-14
Active Ingredient
RIVAROXABAN
Application Number
210301
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2025-05-14
Active Ingredient
RIVAROXABAN
Application Number
210301
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2025-05-14
Active Ingredient
RIVAROXABAN
Application Number
210301
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2012-06-12
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
91689
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2012-06-12
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2012-06-12
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
91689
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2012-06-12
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2012-06-12
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
91689
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2012-06-12
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2012-06-12
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
91689
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2012-06-12
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
2
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
3
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
4
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
5
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
6
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2010-03-24
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
90429
Product Number
7
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2010-03-24
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2013-04-22
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
202786
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2013-04-22
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2013-04-22
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
202786
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2013-04-22
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2013-04-22
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
202786
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2013-04-22
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2013-04-22
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
202786
Product Number
4
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2013-04-22
Regulatory Status
RX
Drug Name
ROPINIROLE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2013-04-22
Active Ingredient
ROPINIROLE HYDROCHLORIDE
Application Number
202786
Product Number
5
Dosage Form
-
Strength
EQ 12MG BASE
Approval Date
2013-04-22
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2024-05-28
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213682
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2024-05-28
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2024-05-28
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213682
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2024-05-28
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2024-05-28
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213682
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2024-05-28
Regulatory Status
RX
Drug Name
SELEXIPAG
Product Number
1
Dosage Form
-
Strength
0.2MG
Approval Date
2023-10-11
Active Ingredient
SELEXIPAG
Application Number
214414
Product Number
1
Dosage Form
-
Strength
0.2MG
Approval Date
2023-10-11
Regulatory Status
RX
Drug Name
SELEXIPAG
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2023-10-11
Active Ingredient
SELEXIPAG
Application Number
214414
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2023-10-11
Regulatory Status
RX
Drug Name
SELEXIPAG
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2023-10-11
Active Ingredient
SELEXIPAG
Application Number
214414
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2023-10-11
Regulatory Status
RX
Drug Name
SELEXIPAG
Product Number
4
Dosage Form
-
Strength
0.8MG
Approval Date
2023-10-11
Active Ingredient
SELEXIPAG
Application Number
214414
Product Number
4
Dosage Form
-
Strength
0.8MG
Approval Date
2023-10-11
Regulatory Status
RX
Drug Name
SELEXIPAG
Product Number
5
Dosage Form
-
Strength
1.4MG
Approval Date
2023-10-11
Active Ingredient
SELEXIPAG
Application Number
214414
Product Number
5
Dosage Form
-
Strength
1.4MG
Approval Date
2023-10-11
Regulatory Status
RX
Drug Name
SELEXIPAG
Product Number
6
Dosage Form
-
Strength
1.6MG
Approval Date
2023-10-11
Active Ingredient
SELEXIPAG
Application Number
214414
Product Number
6
Dosage Form
-
Strength
1.6MG
Approval Date
2023-10-11
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2019-11-22
Active Ingredient
SILODOSIN
Application Number
211731
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2019-11-22
Regulatory Status
Discontinued
Drug Name
SILODOSIN
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2019-11-22
Active Ingredient
SILODOSIN
Application Number
211731
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2019-11-22
Regulatory Status
Discontinued
Drug Name
SOLIFENACIN SUCCINATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-05-20
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
205575
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-05-20
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-05-20
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
205575
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-05-20
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date
2025-11-06
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
213518
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
SUMATRIPTAN SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2025-11-06
Active Ingredient
SUMATRIPTAN SUCCINATE
Application Number
213518
Product Number
2
Dosage Form
-
Strength
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
Approval Date
2025-11-06
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
204809
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
204809
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
204809
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
204809
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TAVABOROLE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2020-10-21
Active Ingredient
TAVABOROLE
Application Number
212188
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2020-10-21
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2014-07-07
Active Ingredient
TELMISARTAN
Application Number
202130
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
202130
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
202130
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
2016-11-17
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
205234
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2016-11-17
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2016-11-17
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
205234
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2016-11-17
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2016-11-17
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
205234
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;80MG
Approval Date
2016-11-17
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND AMLODIPINE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2016-11-17
Active Ingredient
AMLODIPINE BESYLATE; TELMISARTAN
Application Number
205234
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;80MG
Approval Date
2016-11-17
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2014-02-25
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
203010
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2014-02-25
Regulatory Status
RX
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2014-02-25
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
203010
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2014-02-25
Regulatory Status
RX
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2014-02-25
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
203010
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2014-02-25
Regulatory Status
RX
Drug Name
TEMAZEPAM
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2018-11-23
Active Ingredient
TEMAZEPAM
Application Number
211542
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TEMAZEPAM
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2018-11-23
Active Ingredient
TEMAZEPAM
Application Number
211542
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TEMAZEPAM
Product Number
3
Dosage Form
-
Strength
22.5MG
Approval Date
2018-11-23
Active Ingredient
TEMAZEPAM
Application Number
211542
Product Number
3
Dosage Form
-
Strength
22.5MG
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TEMAZEPAM
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2018-11-23
Active Ingredient
TEMAZEPAM
Application Number
211542
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2019-04-19
Active Ingredient
TERIFLUNOMIDE
Application Number
209572
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2019-04-19
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2019-04-19
Active Ingredient
TERIFLUNOMIDE
Application Number
209572
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2019-04-19
Regulatory Status
RX
Drug Name
TESTOSTERONE
Product Number
1
Dosage Form
-
Strength
30MG/1.5ML ACTUATION
Approval Date
2021-06-14
Active Ingredient
TESTOSTERONE
Application Number
212882
Product Number
1
Dosage Form
-
Strength
30MG/1.5ML ACTUATION
Approval Date
2021-06-14
Regulatory Status
Discontinued
Drug Name
TESTOSTERONE
Product Number
1
Dosage Form
-
Strength
1.62% (20.25MG/1.25GM ACTUATION)
Approval Date
2021-03-03
Active Ingredient
TESTOSTERONE
Application Number
213922
Product Number
1
Dosage Form
-
Strength
1.62% (20.25MG/1.25GM ACTUATION)
Approval Date
2021-03-03
Regulatory Status
Discontinued
Drug Name
THEOPHYLLINE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2010-10-27
Active Ingredient
THEOPHYLLINE
Application Number
90430
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2010-10-27
Regulatory Status
RX
Drug Name
THEOPHYLLINE
Product Number
2
Dosage Form
-
Strength
450MG
Approval Date
2010-10-27
Active Ingredient
THEOPHYLLINE
Application Number
90430
Product Number
2
Dosage Form
-
Strength
450MG
Approval Date
2010-10-27
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2025-05-01
Active Ingredient
TICAGRELOR
Application Number
208576
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2025-05-01
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-10-28
Active Ingredient
TICAGRELOR
Application Number
208576
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-10-28
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2020-10-22
Active Ingredient
TIMOLOL MALEATE
Application Number
212942
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2020-10-22
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2020-10-22
Active Ingredient
TIMOLOL MALEATE
Application Number
212942
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2020-10-22
Regulatory Status
RX
Drug Name
TIZANIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2020-01-13
Active Ingredient
TIZANIDINE HYDROCHLORIDE
Application Number
213223
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2020-01-13
Regulatory Status
RX
Drug Name
TIZANIDINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2020-01-13
Active Ingredient
TIZANIDINE HYDROCHLORIDE
Application Number
213223
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2020-01-13
Regulatory Status
RX
Drug Name
TIZANIDINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2020-01-13
Active Ingredient
TIZANIDINE HYDROCHLORIDE
Application Number
213223
Product Number
3
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2020-01-13
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2019-04-19
Active Ingredient
TOBRAMYCIN
Application Number
211847
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2019-04-19
Regulatory Status
RX
Drug Name
TRAVOPROST
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2019-12-20
Active Ingredient
TRAVOPROST
Application Number
210458
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2019-12-20
Regulatory Status
Discontinued
Drug Name
TRAVOPROST
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2025-12-17
Active Ingredient
TRAVOPROST
Application Number
214687
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2025-12-17
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2026-06-11
Active Ingredient
TRETINOIN
Application Number
214590
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2026-06-11
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2024-04-29
Active Ingredient
TRETINOIN
Application Number
217804
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2024-04-29
Regulatory Status
RX
Drug Name
TRETINOIN
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2025-08-14
Active Ingredient
TRETINOIN
Application Number
218399
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2025-08-14
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2025-10-17
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
218601
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2025-10-17
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2015-01-05
Active Ingredient
VALSARTAN
Application Number
91367
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
91367
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
91367
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
91367
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2015-01-05
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201662
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201662
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201662
Product Number
3
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
25MG;160MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201662
Product Number
4
Dosage Form
-
Strength
25MG;160MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2013-03-21
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
201662
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2013-03-21
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-11-16
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
208324
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-11-16
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2020-08-04
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
214031
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2020-08-04
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2020-08-04
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
214031
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2020-08-04
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-08-04
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
214031
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2020-08-04
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-08-04
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
214031
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2020-08-04
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2010-12-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
78932
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2010-12-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2010-12-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
78932
Product Number
2
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2010-12-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2010-12-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
78932
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2010-12-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2010-12-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
78932
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2010-12-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2010-12-14
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
78932
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2010-12-14
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2024-06-06
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
217767
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2024-06-06
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-06-06
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
217767
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-06-06
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-06-06
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
217767
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-06-06
Regulatory Status
RX
Drug Name
VILAZODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-01-10
Active Ingredient
VILAZODONE HYDROCHLORIDE
Application Number
208202
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-01-10
Regulatory Status
RX
Drug Name
VILAZODONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-01-10
Active Ingredient
VILAZODONE HYDROCHLORIDE
Application Number
208202
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-01-10
Regulatory Status
RX
Drug Name
VILAZODONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2020-01-10
Active Ingredient
VILAZODONE HYDROCHLORIDE
Application Number
208202
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2020-01-10
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2015-09-30
Active Ingredient
ZOLMITRIPTAN
Application Number
204232
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2015-09-30
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-09-30
Active Ingredient
ZOLMITRIPTAN
Application Number
204232
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-09-30
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2016-12-01
Active Ingredient
ZOLMITRIPTAN
Application Number
205074
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2016-12-01
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2016-12-01
Active Ingredient
ZOLMITRIPTAN
Application Number
205074
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2016-12-01
Regulatory Status
RX
Drug Status Breakdown
533 total- Unclassified
- RX
- OTC
- Discontinued
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
ACALABRUTINIB
Application Number
216775
Product Number
1
Active Ingredient
ACALABRUTINIB
Dosage Form
-
Strength
100MG
FDA Approved Drug Data
Approved drug product information
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