Lupin Ltd RX
FDA Approved Drugs
Lupin Ltd RX
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 333
- Latest Approval Date Aug 07, 2026
- Data Source FDA
- First Approval Date Jun 19, 1998
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FDA Approved Drug Records ( 333 records )
Drug Name
ALBUTEROL SULFATE
Product Number
1
Dosage Form
-
Strength
EQ 0.09MG BASE/INH
Approval Date
2020-08-24
Active Ingredient
ALBUTEROL SULFATE
Application Number
209954
Product Number
1
Dosage Form
-
Strength
EQ 0.09MG BASE/INH
Approval Date
2020-08-24
Regulatory Status
RX
Drug Name
AMABELZ
Product Number
1
Dosage Form
-
Strength
0.5MG;0.1MG
Approval Date
2016-06-20
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Application Number
203339
Product Number
1
Dosage Form
-
Strength
0.5MG;0.1MG
Approval Date
2016-06-20
Regulatory Status
RX
Drug Name
AMABELZ
Product Number
2
Dosage Form
-
Strength
1MG;0.5MG
Approval Date
2016-06-20
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Application Number
203339
Product Number
2
Dosage Form
-
Strength
1MG;0.5MG
Approval Date
2016-06-20
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2007-07-12
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78043
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2007-07-12
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2007-07-12
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78043
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2007-07-12
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-07-12
Active Ingredient
AMLODIPINE BESYLATE
Application Number
78043
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2007-07-12
Regulatory Status
RX
Drug Name
ANTARA (MICRONIZED)
Product Number
1
Dosage Form
-
Strength
43MG
Approval Date
2004-11-30
Active Ingredient
FENOFIBRATE
Application Number
21695
Product Number
1
Dosage Form
-
Strength
43MG
Approval Date
2004-11-30
Regulatory Status
RX
Drug Name
ANTARA (MICRONIZED)
Product Number
3
Dosage Form
-
Strength
130MG
Approval Date
2004-11-30
Active Ingredient
FENOFIBRATE
Application Number
21695
Product Number
3
Dosage Form
-
Strength
130MG
Approval Date
2004-11-30
Regulatory Status
RX
Drug Name
ARFORMOTEROL TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2022-02-07
Active Ingredient
ARFORMOTEROL TARTRATE
Application Number
213068
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2022-02-07
Regulatory Status
RX
Drug Name
AZILSARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
EQ 40MG MEDOXOMIL
Approval Date
2022-07-20
Active Ingredient
AZILSARTAN KAMEDOXOMIL
Application Number
214489
Product Number
1
Dosage Form
-
Strength
EQ 40MG MEDOXOMIL
Approval Date
2022-07-20
Regulatory Status
RX
Drug Name
AZILSARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
EQ 80MG MEDOXOMIL
Approval Date
2022-07-20
Active Ingredient
AZILSARTAN KAMEDOXOMIL
Application Number
214489
Product Number
2
Dosage Form
-
Strength
EQ 80MG MEDOXOMIL
Approval Date
2022-07-20
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2015-05-15
Active Ingredient
AZITHROMYCIN
Application Number
65398
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2015-05-15
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2015-05-15
Active Ingredient
AZITHROMYCIN
Application Number
65399
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2015-05-15
Regulatory Status
RX
Drug Name
AZITHROMYCIN
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2015-05-15
Active Ingredient
AZITHROMYCIN
Application Number
65400
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2015-05-15
Regulatory Status
RX
Drug Name
BEKYREE
Product Number
1
Dosage Form
-
Strength
0.15MG,N/A;0.02MG,0.01MG
Approval Date
2015-08-12
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
202226
Product Number
1
Dosage Form
-
Strength
0.15MG,N/A;0.02MG,0.01MG
Approval Date
2015-08-12
Regulatory Status
RX
Drug Name
BETAMETHASONE DIPROPIONATE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
2019-12-18
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
209106
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
2019-12-18
Regulatory Status
RX
Drug Name
BLISOVI 24 FE
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2015-10-28
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
91398
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2015-10-28
Regulatory Status
RX
Drug Name
BLISOVI FE 1.5/30
Product Number
1
Dosage Form
-
Strength
0.03MG;1.5MG
Approval Date
2015-11-18
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
201585
Product Number
1
Dosage Form
-
Strength
0.03MG;1.5MG
Approval Date
2015-11-18
Regulatory Status
RX
Drug Name
BLISOVI FE 1/20
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2015-11-18
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
201584
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2015-11-18
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2024-08-26
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
213215
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2024-08-26
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-02-23
Active Ingredient
BRIVARACETAM
Application Number
220164
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-02-23
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2023-08-15
Active Ingredient
BROMFENAC SODIUM
Application Number
202903
Product Number
1
Dosage Form
-
Strength
EQ 0.09% ACID
Approval Date
2023-08-15
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.07% ACID
Approval Date
2023-11-22
Active Ingredient
BROMFENAC SODIUM
Application Number
206027
Product Number
1
Dosage Form
-
Strength
EQ 0.07% ACID
Approval Date
2023-11-22
Regulatory Status
RX
Drug Name
BROMFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 0.075% ACID
Approval Date
2024-02-02
Active Ingredient
BROMFENAC SODIUM
Application Number
211239
Product Number
1
Dosage Form
-
Strength
EQ 0.075% ACID
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
BUDESONIDE
Product Number
1
Dosage Form
-
Strength
0.5MG/2ML
Approval Date
2018-11-09
Active Ingredient
BUDESONIDE
Application Number
210897
Product Number
1
Dosage Form
-
Strength
0.5MG/2ML
Approval Date
2018-11-09
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2024-09-17
Active Ingredient
BUMETANIDE
Application Number
217153
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2024-09-17
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2017-04-06
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
90693
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2017-04-06
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2017-04-06
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
90693
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2017-04-06
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2007-05-29
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
65392
Product Number
1
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2007-05-29
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2008-02-21
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
65396
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2008-02-21
Regulatory Status
RX
Drug Name
CEFADROXIL
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML
Approval Date
2008-02-21
Active Ingredient
CEFADROXIL/CEFADROXIL HEMIHYDRATE
Application Number
65396
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML
Approval Date
2008-02-21
Regulatory Status
RX
Drug Name
CEFDINIR
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2006-05-31
Active Ingredient
CEFDINIR
Application Number
65259
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2006-05-31
Regulatory Status
RX
Drug Name
CEFDINIR
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-05-07
Active Ingredient
CEFDINIR
Application Number
65259
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2007-05-07
Regulatory Status
RX
Drug Name
CEFDINIR
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2006-05-19
Active Ingredient
CEFDINIR
Application Number
65264
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2006-05-19
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2005-12-19
Active Ingredient
CEFPROZIL
Application Number
65261
Product Number
1
Dosage Form
-
Strength
125MG/5ML
Approval Date
2005-12-19
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2005-12-19
Active Ingredient
CEFPROZIL
Application Number
65261
Product Number
2
Dosage Form
-
Strength
250MG/5ML
Approval Date
2005-12-19
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2005-12-08
Active Ingredient
CEFPROZIL
Application Number
65276
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2005-12-08
Regulatory Status
RX
Drug Name
CEFPROZIL
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2005-12-08
Active Ingredient
CEFPROZIL
Application Number
65276
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2005-12-08
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2014-10-29
Active Ingredient
CELECOXIB
Application Number
202240
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2014-10-29
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-06-09
Active Ingredient
CELECOXIB
Application Number
202240
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2015-06-09
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2015-06-09
Active Ingredient
CELECOXIB
Application Number
202240
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2015-06-09
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2015-06-09
Active Ingredient
CELECOXIB
Application Number
202240
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2015-06-09
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2005-11-25
Active Ingredient
CEPHALEXIN
Application Number
65229
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE
Approval Date
2005-11-25
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2005-11-25
Active Ingredient
CEPHALEXIN
Application Number
65229
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE
Approval Date
2005-11-25
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
2005-08-17
Active Ingredient
CEPHALEXIN
Application Number
65234
Product Number
1
Dosage Form
-
Strength
EQ 125MG BASE/5ML
Approval Date
2005-08-17
Regulatory Status
RX
Drug Name
CEPHALEXIN
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2005-08-17
Active Ingredient
CEPHALEXIN
Application Number
65234
Product Number
2
Dosage Form
-
Strength
EQ 250MG BASE/5ML
Approval Date
2005-08-17
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-07-13
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
213327
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-07-13
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-07-13
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
213327
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2023-07-13
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2023-07-13
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
213327
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2023-07-13
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2023-07-13
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
213327
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2023-07-13
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-07-13
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
213327
Product Number
5
Dosage Form
-
Strength
200MG
Approval Date
2023-07-13
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-12-14
Active Ingredient
CLOBAZAM
Application Number
210545
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2018-12-14
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2018-12-14
Active Ingredient
CLOBAZAM
Application Number
210545
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2018-12-14
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2017-09-22
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
209147
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2017-09-22
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2018-01-30
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
210208
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2018-01-30
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2018-11-21
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
209294
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2018-11-21
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2018-11-21
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
209294
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2018-11-21
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2018-11-21
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
209294
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2018-11-21
Regulatory Status
RX
Drug Name
CYANOCOBALAMIN
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY
Approval Date
2023-06-30
Active Ingredient
CYANOCOBALAMIN
Application Number
210629
Product Number
1
Dosage Form
-
Strength
0.5MG/SPRAY
Approval Date
2023-06-30
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211531
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
211531
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG;500MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211579
Product Number
1
Dosage Form
-
Strength
5MG;500MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG;1GM
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211579
Product Number
2
Dosage Form
-
Strength
5MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG;500MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211579
Product Number
3
Dosage Form
-
Strength
10MG;500MG
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Application Number
211579
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2022-09-29
Active Ingredient
DARUNAVIR
Application Number
202073
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2022-09-29
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2022-09-29
Active Ingredient
DARUNAVIR
Application Number
202073
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2022-09-29
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-08-25
Active Ingredient
DASATINIB
Application Number
214350
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-08-25
Active Ingredient
DASATINIB
Application Number
214350
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
3
Dosage Form
-
Strength
70MG
Approval Date
2025-08-25
Active Ingredient
DASATINIB
Application Number
214350
Product Number
3
Dosage Form
-
Strength
70MG
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2025-08-25
Active Ingredient
DASATINIB
Application Number
214350
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-08-25
Active Ingredient
DASATINIB
Application Number
214350
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
DASATINIB
Product Number
6
Dosage Form
-
Strength
140MG
Approval Date
2025-08-25
Active Ingredient
DASATINIB
Application Number
214350
Product Number
6
Dosage Form
-
Strength
140MG
Approval Date
2025-08-25
Regulatory Status
RX
Drug Name
DAYSEE
Product Number
1
Dosage Form
-
Strength
0.03MG,0.01MG;0.15MG,N/A
Approval Date
2013-04-10
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
91467
Product Number
1
Dosage Form
-
Strength
0.03MG,0.01MG;0.15MG,N/A
Approval Date
2013-04-10
Regulatory Status
RX
Drug Name
DESOXIMETASONE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2016-12-12
Active Ingredient
DESOXIMETASONE
Application Number
208044
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2016-12-12
Regulatory Status
RX
Drug Name
DESOXIMETASONE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2016-12-01
Active Ingredient
DESOXIMETASONE
Application Number
208104
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2016-12-01
Regulatory Status
RX
Drug Name
DESOXIMETASONE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2018-03-16
Active Ingredient
DESOXIMETASONE
Application Number
208124
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2018-03-16
Regulatory Status
RX
Drug Name
DESOXIMETASONE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2017-01-10
Active Ingredient
DESOXIMETASONE
Application Number
208163
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2017-01-10
Regulatory Status
RX
Drug Name
DESOXIMETASONE
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2017-01-09
Active Ingredient
DESOXIMETASONE
Application Number
208164
Product Number
1
Dosage Form
-
Strength
0.25%
Approval Date
2017-01-09
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
204172
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
204172
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
2022-04-13
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
204172
Product Number
3
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2022-04-13
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
1
Dosage Form
-
Strength
1.25MG;1.25MG;1.25MG;1.25MG
Approval Date
2024-11-07
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
214777
Product Number
1
Dosage Form
-
Strength
1.25MG;1.25MG;1.25MG;1.25MG
Approval Date
2024-11-07
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
2
Dosage Form
-
Strength
2.5MG;2.5MG;2.5MG;2.5MG
Approval Date
2024-11-07
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
214777
Product Number
2
Dosage Form
-
Strength
2.5MG;2.5MG;2.5MG;2.5MG
Approval Date
2024-11-07
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
3
Dosage Form
-
Strength
3.75MG;3.75MG;3.75MG;3.75MG
Approval Date
2024-11-07
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
214777
Product Number
3
Dosage Form
-
Strength
3.75MG;3.75MG;3.75MG;3.75MG
Approval Date
2024-11-07
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
4
Dosage Form
-
Strength
5MG;5MG;5MG;5MG
Approval Date
2024-11-07
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
214777
Product Number
4
Dosage Form
-
Strength
5MG;5MG;5MG;5MG
Approval Date
2024-11-07
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
5
Dosage Form
-
Strength
6.25MG;6.25MG;6.25MG;6.25MG
Approval Date
2024-11-07
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
214777
Product Number
5
Dosage Form
-
Strength
6.25MG;6.25MG;6.25MG;6.25MG
Approval Date
2024-11-07
Regulatory Status
RX
Drug Name
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Product Number
6
Dosage Form
-
Strength
7.5MG;7.5MG;7.5MG;7.5MG
Approval Date
2024-11-07
Active Ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Application Number
214777
Product Number
6
Dosage Form
-
Strength
7.5MG;7.5MG;7.5MG;7.5MG
Approval Date
2024-11-07
Regulatory Status
RX
Drug Name
DIAZEPAM
Product Number
1
Dosage Form
-
Strength
10MG/2ML (5MG/ML)
Approval Date
2026-07-27
Active Ingredient
DIAZEPAM
Application Number
220365
Product Number
1
Dosage Form
-
Strength
10MG/2ML (5MG/ML)
Approval Date
2026-07-27
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2015-08-20
Active Ingredient
DICLOFENAC SODIUM
Application Number
204132
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2015-08-20
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2020-10-05
Active Ingredient
DIMETHYL FUMARATE
Application Number
210226
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2020-10-05
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2020-10-05
Active Ingredient
DIMETHYL FUMARATE
Application Number
210226
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2020-10-05
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2019-10-18
Active Ingredient
DIVALPROEX SODIUM
Application Number
209286
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2019-10-18
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2019-10-18
Active Ingredient
DIVALPROEX SODIUM
Application Number
209286
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2019-10-18
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Product Number
1
Dosage Form
-
Strength
20MG/10ML (2MG/ML)
Approval Date
2024-07-16
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
215178
Product Number
1
Dosage Form
-
Strength
20MG/10ML (2MG/ML)
Approval Date
2024-07-16
Regulatory Status
RX
Drug Name
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
Product Number
2
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2024-07-16
Active Ingredient
DOXORUBICIN HYDROCHLORIDE
Application Number
215178
Product Number
2
Dosage Form
-
Strength
50MG/25ML (2MG/ML)
Approval Date
2024-07-16
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML
Approval Date
2013-03-18
Active Ingredient
DOXYCYCLINE
Application Number
201678
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE/5ML
Approval Date
2013-03-18
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2014-03-05
Active Ingredient
DOXYCYCLINE
Application Number
204234
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2014-03-05
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2014-03-05
Active Ingredient
DOXYCYCLINE
Application Number
204234
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2014-03-05
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2014-03-05
Active Ingredient
DOXYCYCLINE
Application Number
204234
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2014-03-05
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2024-04-08
Active Ingredient
DOXYCYCLINE
Application Number
216631
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2024-04-08
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-09-27
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
208818
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-09-27
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-09-27
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
208818
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-09-27
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2024-03-14
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
217794
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE/VIAL
Approval Date
2024-03-14
Regulatory Status
RX
Drug Name
DROSPIRENONE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
3MG;0.03MG
Approval Date
2012-12-18
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
201663
Product Number
1
Dosage Form
-
Strength
3MG;0.03MG
Approval Date
2012-12-18
Regulatory Status
RX
Drug Name
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date
2018-06-13
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Application Number
205947
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
Approval Date
2018-06-13
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90694
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90694
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90694
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-12-11
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
90694
Product Number
4
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2013-12-11
Regulatory Status
RX
Drug Name
ENSKYCE
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG
Approval Date
2013-03-07
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
201887
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG
Approval Date
2013-03-07
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-03-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211246
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2024-03-27
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2024-03-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211246
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2024-03-27
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2024-03-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211246
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2024-03-27
Regulatory Status
RX
Drug Name
ESLICARBAZEPINE ACETATE
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2024-03-27
Active Ingredient
ESLICARBAZEPINE ACETATE
Application Number
211246
Product Number
4
Dosage Form
-
Strength
800MG
Approval Date
2024-03-27
Regulatory Status
RX
Drug Name
ETHACRYNIC ACID
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-09-06
Active Ingredient
ETHACRYNIC ACID
Application Number
211719
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-09-06
Regulatory Status
RX
Drug Name
ETHAMBUTOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2009-06-17
Active Ingredient
ETHAMBUTOL HYDROCHLORIDE
Application Number
78939
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2009-06-17
Regulatory Status
RX
Drug Name
ETHAMBUTOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2009-06-17
Active Ingredient
ETHAMBUTOL HYDROCHLORIDE
Application Number
78939
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2009-06-17
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2010-06-29
Active Ingredient
FAMOTIDINE
Application Number
90440
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2010-06-29
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-05-12
Active Ingredient
FAMOTIDINE
Application Number
217432
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-05-12
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2011-12-23
Active Ingredient
FENOFIBRATE
Application Number
90856
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2011-12-23
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2011-12-23
Active Ingredient
FENOFIBRATE
Application Number
90856
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2011-12-23
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2015-08-17
Active Ingredient
FENOFIBRATE
Application Number
204019
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2015-08-17
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2015-08-17
Active Ingredient
FENOFIBRATE
Application Number
204019
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2015-08-17
Regulatory Status
RX
Drug Name
FLUOCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2015-09-02
Active Ingredient
FLUOCINOLONE ACETONIDE
Application Number
206422
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2015-09-02
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-04-15
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
211653
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-04-15
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-04-15
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
211653
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-04-15
Regulatory Status
RX
Drug Name
FORMOTEROL FUMARATE
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2022-08-22
Active Ingredient
FORMOTEROL FUMARATE
Application Number
215053
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2022-08-22
Regulatory Status
RX
Drug Name
FYAVOLV
Product Number
1
Dosage Form
-
Strength
0.0025MG;0.5MG
Approval Date
2015-12-10
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
204213
Product Number
1
Dosage Form
-
Strength
0.0025MG;0.5MG
Approval Date
2015-12-10
Regulatory Status
RX
Drug Name
FYAVOLV
Product Number
2
Dosage Form
-
Strength
0.005MG;1MG
Approval Date
2015-12-10
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
204213
Product Number
2
Dosage Form
-
Strength
0.005MG;1MG
Approval Date
2015-12-10
Regulatory Status
RX
Drug Name
GANIRELIX ACETATE
Product Number
1
Dosage Form
-
Strength
250MCG/0.5ML
Approval Date
2023-11-16
Active Ingredient
GANIRELIX ACETATE
Application Number
216075
Product Number
1
Dosage Form
-
Strength
250MCG/0.5ML
Approval Date
2023-11-16
Regulatory Status
RX
Drug Name
GLUCAGON
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2025-07-22
Active Ingredient
GLUCAGON
Application Number
214457
Product Number
1
Dosage Form
-
Strength
1MG/VIAL
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
GLYCEROL PHENYLBUTYRATE
Product Number
1
Dosage Form
-
Strength
1.1GM/ML
Approval Date
2026-04-30
Active Ingredient
GLYCEROL PHENYLBUTYRATE
Application Number
207694
Product Number
1
Dosage Form
-
Strength
1.1GM/ML
Approval Date
2026-04-30
Regulatory Status
RX
Drug Name
HYDROCORTISONE BUTYRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2018-08-17
Active Ingredient
HYDROCORTISONE BUTYRATE
Application Number
210209
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2018-08-17
Regulatory Status
RX
Drug Name
HYDROCORTISONE VALERATE
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2019-08-15
Active Ingredient
HYDROCORTISONE VALERATE
Application Number
210307
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2019-08-15
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
90444
Product Number
1
Dosage Form
-
Strength
EQ 75MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
90444
Product Number
2
Dosage Form
-
Strength
EQ 100MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
3
Dosage Form
-
Strength
EQ 125MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
90444
Product Number
3
Dosage Form
-
Strength
EQ 125MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IMIPRAMINE PAMOATE
Product Number
4
Dosage Form
-
Strength
EQ 150MG HYDROCHLORIDE
Approval Date
2010-04-16
Active Ingredient
IMIPRAMINE PAMOATE
Application Number
90444
Product Number
4
Dosage Form
-
Strength
EQ 150MG HYDROCHLORIDE
Approval Date
2010-04-16
Regulatory Status
RX
Drug Name
IPRATROPIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
0.042MG/SPRAY
Approval Date
2025-01-27
Active Ingredient
IPRATROPIUM BROMIDE
Application Number
217886
Product Number
1
Dosage Form
-
Strength
0.042MG/SPRAY
Approval Date
2025-01-27
Regulatory Status
RX
Drug Name
IPRATROPIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
0.021MG/SPRAY
Approval Date
2025-02-07
Active Ingredient
IPRATROPIUM BROMIDE
Application Number
217912
Product Number
1
Dosage Form
-
Strength
0.021MG/SPRAY
Approval Date
2025-02-07
Regulatory Status
RX
Drug Name
JENCYCLA
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2013-03-28
Active Ingredient
NORETHINDRONE
Application Number
91323
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2013-03-28
Regulatory Status
RX
Drug Name
KAITLIB FE
Product Number
1
Dosage Form
-
Strength
0.025MG;0.8MG
Approval Date
2015-12-17
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
203448
Product Number
1
Dosage Form
-
Strength
0.025MG;0.8MG
Approval Date
2015-12-17
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE AND PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE;EQ 1% BASE
Approval Date
2019-07-01
Active Ingredient
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Application Number
210183
Product Number
1
Dosage Form
-
Strength
EQ 0.3% BASE;EQ 1% BASE
Approval Date
2019-07-01
Regulatory Status
RX
Drug Name
KURVELO
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2012-10-17
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
91408
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2012-10-17
Regulatory Status
RX
Drug Name
LEFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-02-04
Active Ingredient
LEFLUNOMIDE
Application Number
211863
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-02-04
Regulatory Status
RX
Drug Name
LEFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-02-04
Active Ingredient
LEFLUNOMIDE
Application Number
211863
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-02-04
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-09-16
Active Ingredient
LENALIDOMIDE
Application Number
214398
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-09-16
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2025-09-16
Active Ingredient
LENALIDOMIDE
Application Number
214398
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2025-09-16
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2025-09-16
Active Ingredient
LENALIDOMIDE
Application Number
214398
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2025-09-16
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2025-09-16
Active Ingredient
LENALIDOMIDE
Application Number
214398
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2025-09-16
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2025-09-16
Active Ingredient
LENALIDOMIDE
Application Number
214398
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2025-09-16
Regulatory Status
RX
Drug Name
LENALIDOMIDE
Product Number
6
Dosage Form
-
Strength
25MG
Approval Date
2025-09-16
Active Ingredient
LENALIDOMIDE
Application Number
214398
Product Number
6
Dosage Form
-
Strength
25MG
Approval Date
2025-09-16
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78154
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78154
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
78154
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2009-01-15
Active Ingredient
LEVETIRACETAM
Application Number
90025
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2009-01-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2011-09-12
Active Ingredient
LEVETIRACETAM
Application Number
91399
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2011-09-12
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2011-09-12
Active Ingredient
LEVETIRACETAM
Application Number
91399
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2011-09-12
Regulatory Status
RX
Drug Name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG
Approval Date
2013-01-18
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
91425
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG
Approval Date
2013-01-18
Regulatory Status
RX
Drug Name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2012-10-23
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
91440
Product Number
1
Dosage Form
-
Strength
0.03MG;0.15MG
Approval Date
2012-10-23
Regulatory Status
RX
Drug Name
LEVONORGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date
2015-11-19
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
200248
Product Number
1
Dosage Form
-
Strength
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG
Approval Date
2015-11-19
Regulatory Status
RX
Drug Name
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.02MG,0.1MG;0.01MG,N/A
Approval Date
2011-10-26
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
91674
Product Number
1
Dosage Form
-
Strength
0.02MG,0.1MG;0.01MG,N/A
Approval Date
2011-10-26
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
11
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
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
2019-01-18
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
209713
Product Number
12
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2019-01-18
Regulatory Status
RX
Drug Name
LIRAGLUTIDE
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2025-07-22
Active Ingredient
LIRAGLUTIDE
Application Number
215421
Product Number
1
Dosage Form
-
Strength
18MG/3ML (6MG/ML)
Approval Date
2025-07-22
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2005-09-09
Active Ingredient
LISINOPRIL
Application Number
77321
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2005-09-09
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2005-09-09
Active Ingredient
LISINOPRIL
Application Number
77321
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2005-09-09
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2005-09-09
Active Ingredient
LISINOPRIL
Application Number
77321
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2005-09-09
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2005-09-09
Active Ingredient
LISINOPRIL
Application Number
77321
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2005-09-09
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2005-09-09
Active Ingredient
LISINOPRIL
Application Number
77321
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2005-09-09
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2005-09-09
Active Ingredient
LISINOPRIL
Application Number
77321
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2005-09-09
Regulatory Status
RX
Drug Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;10MG
Approval Date
2006-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; LISINOPRIL
Application Number
77912
Product Number
1
Dosage Form
-
Strength
12.5MG;10MG
Approval Date
2006-09-27
Regulatory Status
RX
Drug Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2006-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; LISINOPRIL
Application Number
77912
Product Number
2
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2006-09-27
Regulatory Status
RX
Drug Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;20MG
Approval Date
2006-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; LISINOPRIL
Application Number
77912
Product Number
3
Dosage Form
-
Strength
25MG;20MG
Approval Date
2006-09-27
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2010-10-06
Active Ingredient
LOSARTAN POTASSIUM
Application Number
78232
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
78232
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
78232
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2010-10-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
78245
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-05-21
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
78245
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2010-05-21
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-10-06
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
78245
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2010-10-06
Regulatory Status
RX
Drug Name
LOTEPREDNOL ETABONATE
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2023-12-26
Active Ingredient
LOTEPREDNOL ETABONATE
Application Number
215550
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2023-12-26
Regulatory Status
RX
Drug Name
LOTEPREDNOL ETABONATE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2024-04-24
Active Ingredient
LOTEPREDNOL ETABONATE
Application Number
215719
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2024-04-24
Regulatory Status
RX
Drug Name
LOTEPREDNOL ETABONATE
Product Number
1
Dosage Form
-
Strength
0.38%
Approval Date
2025-06-30
Active Ingredient
LOTEPREDNOL ETABONATE
Application Number
218087
Product Number
1
Dosage Form
-
Strength
0.38%
Approval Date
2025-06-30
Regulatory Status
RX
Drug Name
LOVASTATIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2008-03-14
Active Ingredient
LOVASTATIN
Application Number
78296
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2008-03-14
Regulatory Status
RX
Drug Name
LOVASTATIN
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2007-11-01
Active Ingredient
LOVASTATIN
Application Number
78296
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2007-11-01
Regulatory Status
RX
Drug Name
LOVASTATIN
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2007-11-01
Active Ingredient
LOVASTATIN
Application Number
78296
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2007-11-01
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208031
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208031
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208031
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208031
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2019-01-03
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208031
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2019-01-03
Regulatory Status
RX
Drug Name
MEFENAMIC ACID
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-07-22
Active Ingredient
MEFENAMIC ACID
Application Number
91322
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2011-07-22
Regulatory Status
RX
Drug Name
MELOXICAM
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2020-06-01
Active Ingredient
MELOXICAM
Application Number
209487
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2020-06-01
Regulatory Status
RX
Drug Name
MELOXICAM
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2020-06-01
Active Ingredient
MELOXICAM
Application Number
209487
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2020-06-01
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-04-10
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
90051
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-04-10
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-04-10
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
90051
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-04-10
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2016-09-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206028
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2016-09-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2016-09-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206028
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2016-09-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
21MG
Approval Date
2016-09-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206028
Product Number
3
Dosage Form
-
Strength
21MG
Approval Date
2016-09-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
28MG
Approval Date
2016-09-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206028
Product Number
4
Dosage Form
-
Strength
28MG
Approval Date
2016-09-28
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2011-06-29
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
90692
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2011-06-29
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
90692
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2011-06-29
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2013-07-19
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
91664
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2013-07-19
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2013-07-19
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
91664
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2013-07-19
Regulatory Status
RX
Drug Name
MIBELAS 24 FE
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2016-05-24
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Application Number
206287
Product Number
1
Dosage Form
-
Strength
0.02MG;1MG
Approval Date
2016-05-24
Regulatory Status
RX
Drug Name
MIDOSTAURIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2024-05-10
Active Ingredient
MIDOSTAURIN
Application Number
216015
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2024-05-10
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2011-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
91424
Product Number
1
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2011-11-30
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 55MG BASE
Approval Date
2011-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
91424
Product Number
2
Dosage Form
-
Strength
EQ 55MG BASE
Approval Date
2011-11-30
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2011-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
91424
Product Number
3
Dosage Form
-
Strength
EQ 90MG BASE
Approval Date
2011-11-30
Regulatory Status
RX
Drug Name
MINOCYCLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 135MG BASE
Approval Date
2011-11-30
Active Ingredient
MINOCYCLINE HYDROCHLORIDE
Application Number
91424
Product Number
4
Dosage Form
-
Strength
EQ 135MG BASE
Approval Date
2011-11-30
Regulatory Status
RX
Drug Name
MINZOYA
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG
Approval Date
2024-02-15
Active Ingredient
ETHINYL ESTRADIOL; LEVONORGESTREL
Application Number
217087
Product Number
1
Dosage Form
-
Strength
0.02MG;0.1MG
Approval Date
2024-02-15
Regulatory Status
RX
Drug Name
MIRABEGRON
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-09-28
Active Ingredient
MIRABEGRON
Application Number
209485
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-09-28
Regulatory Status
RX
Drug Name
MIRABEGRON
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-09-28
Active Ingredient
MIRABEGRON
Application Number
209485
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-09-28
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2014-09-04
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
202867
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2014-09-04
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2015-05-28
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
204079
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2015-05-28
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE;EQ 50MG BASE
Approval Date
2001-07-11
Active Ingredient
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE
Application Number
75735
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE;EQ 50MG BASE
Approval Date
2001-07-11
Regulatory Status
RX
Drug Name
NIKKI
Product Number
1
Dosage Form
-
Strength
3MG;0.02MG
Approval Date
2014-05-27
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL
Application Number
201661
Product Number
1
Dosage Form
-
Strength
3MG;0.02MG
Approval Date
2014-05-27
Regulatory Status
RX
Drug Name
NORETHINDRONE
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2011-09-19
Active Ingredient
NORETHINDRONE
Application Number
91325
Product Number
1
Dosage Form
-
Strength
0.35MG
Approval Date
2011-09-19
Regulatory Status
RX
Drug Name
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2016-03-23
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
91332
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2016-03-23
Regulatory Status
RX
Drug Name
NORGESTIMATE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date
2016-04-26
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
205588
Product Number
1
Dosage Form
-
Strength
0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG
Approval Date
2016-04-26
Regulatory Status
RX
Drug Name
NORGESTIMATE AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG
Approval Date
2016-10-27
Active Ingredient
ETHINYL ESTRADIOL; NORGESTIMATE
Application Number
205630
Product Number
1
Dosage Form
-
Strength
0.035MG;0.25MG
Approval Date
2016-10-27
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2004-07-23
Active Ingredient
NYSTATIN
Application Number
65138
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2004-07-23
Regulatory Status
RX
Drug Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2018-05-31
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
208205
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2018-05-31
Regulatory Status
RX
Drug Name
ORPHENADRINE CITRATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1998-06-19
Active Ingredient
ORPHENADRINE CITRATE
Application Number
40284
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1998-06-19
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2018-02-20
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
208347
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2018-02-20
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2018-01-09
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
208348
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2018-01-09
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2018-01-09
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
208348
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2018-01-09
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2018-01-09
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
208348
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2018-01-09
Regulatory Status
RX
Drug Name
PENICILLAMINE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2020-11-30
Active Ingredient
PENICILLAMINE
Application Number
212933
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2020-11-30
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-11-20
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206029
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-11-20
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-11-20
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206029
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2023-11-20
Regulatory Status
RX
Drug Name
PITAVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2023-11-20
Active Ingredient
PITAVASTATIN CALCIUM
Application Number
206029
Product Number
3
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2023-11-20
Regulatory Status
RX
Drug Name
PREDNISOLONE ACETATE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2024-08-02
Active Ingredient
PREDNISOLONE ACETATE
Application Number
216935
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2024-08-02
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
218847
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
218847
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
201109
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
201109
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
201109
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
201109
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
201109
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Active Ingredient
QUETIAPINE FUMARATE
Application Number
201109
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2012-03-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2017-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204203
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2017-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204203
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2017-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204203
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2017-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2017-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204203
Product Number
4
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2017-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204203
Product Number
5
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-05-17
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2006-06-20
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
77690
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2006-06-20
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2006-06-20
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
77690
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2006-06-20
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2006-06-20
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
77690
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2006-06-20
Regulatory Status
RX
Drug Name
QUINAPRIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2006-06-20
Active Ingredient
QUINAPRIL HYDROCHLORIDE
Application Number
77690
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2006-06-20
Regulatory Status
RX
Drug Name
QUININE SULFATE
Product Number
1
Dosage Form
-
Strength
324MG
Approval Date
2015-04-24
Active Ingredient
QUININE SULFATE
Application Number
203112
Product Number
1
Dosage Form
-
Strength
324MG
Approval Date
2015-04-24
Regulatory Status
RX
Drug Name
RALTEGRAVIR POTASSIUM
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2025-05-06
Active Ingredient
RALTEGRAVIR POTASSIUM
Application Number
217990
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE
Approval Date
2025-05-06
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2008-06-09
Active Ingredient
RAMIPRIL
Application Number
77626
Product Number
1
Dosage Form
-
Strength
1.25MG
Approval Date
2008-06-09
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2008-06-09
Active Ingredient
RAMIPRIL
Application Number
77626
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2008-06-09
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2008-06-09
Active Ingredient
RAMIPRIL
Application Number
77626
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2008-06-09
Regulatory Status
RX
Drug Name
RAMIPRIL
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2008-06-09
Active Ingredient
RAMIPRIL
Application Number
77626
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2008-06-09
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-03-03
Active Ingredient
RIVAROXABAN
Application Number
208555
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-03-03
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2025-05-14
Active Ingredient
RIVAROXABAN
Application Number
208555
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
208555
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
208555
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2025-05-14
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2025-09-25
Active Ingredient
RIVAROXABAN
Application Number
218195
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2025-09-25
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2022-08-17
Active Ingredient
RUFINAMIDE
Application Number
204964
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2022-08-17
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2022-08-17
Active Ingredient
RUFINAMIDE
Application Number
204964
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2022-08-17
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2022-08-17
Active Ingredient
RUFINAMIDE
Application Number
204964
Product Number
3
Dosage Form
-
Strength
400MG
Approval Date
2022-08-17
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2020-12-18
Active Ingredient
RUFINAMIDE
Application Number
213457
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2020-12-18
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2025-01-08
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213808
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2025-01-08
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2025-01-08
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213808
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2025-01-08
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2025-01-08
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213808
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2025-01-08
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77670
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77670
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SERTRALINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Active Ingredient
SERTRALINE HYDROCHLORIDE
Application Number
77670
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2007-02-06
Regulatory Status
RX
Drug Name
SEVELAMER HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2021-06-16
Active Ingredient
SEVELAMER HYDROCHLORIDE
Application Number
213145
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2021-06-16
Regulatory Status
RX
Drug Name
SEVELAMER HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2021-06-16
Active Ingredient
SEVELAMER HYDROCHLORIDE
Application Number
213145
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2021-06-16
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-03
Active Ingredient
SILODOSIN
Application Number
206541
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-03
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-03
Active Ingredient
SILODOSIN
Application Number
206541
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-03
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2007-05-11
Active Ingredient
SIMVASTATIN
Application Number
78103
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2007-05-11
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2007-05-11
Active Ingredient
SIMVASTATIN
Application Number
78103
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2007-05-11
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2007-05-11
Active Ingredient
SIMVASTATIN
Application Number
78103
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2007-05-11
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2007-05-11
Active Ingredient
SIMVASTATIN
Application Number
78103
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2007-05-11
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
2009-04-14
Active Ingredient
SIMVASTATIN
Application Number
78103
Product Number
5
Dosage Form
-
Strength
5MG
Approval Date
2009-04-14
Regulatory Status
RX
Drug Name
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
0.225GM;0.188GM;1.479GM
Approval Date
2026-05-28
Active Ingredient
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE
Application Number
216095
Product Number
1
Dosage Form
-
Strength
0.225GM;0.188GM;1.479GM
Approval Date
2026-05-28
Regulatory Status
RX
Drug Name
SODIUM ZIRCONIUM CYCLOSILICATE
Product Number
1
Dosage Form
-
Strength
5GM/PACKET
Approval Date
2026-08-07
Active Ingredient
SODIUM ZIRCONIUM CYCLOSILICATE
Application Number
217549
Product Number
1
Dosage Form
-
Strength
5GM/PACKET
Approval Date
2026-08-07
Regulatory Status
RX
Drug Name
SODIUM ZIRCONIUM CYCLOSILICATE
Product Number
2
Dosage Form
-
Strength
10GM/PACKET
Approval Date
2026-08-07
Active Ingredient
SODIUM ZIRCONIUM CYCLOSILICATE
Application Number
217549
Product Number
2
Dosage Form
-
Strength
10GM/PACKET
Approval Date
2026-08-07
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
214338
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
214338
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUPRAX
Product Number
1
Dosage Form
-
Strength
500MG/5ML
Approval Date
2013-02-20
Active Ingredient
CEFIXIME
Application Number
202091
Product Number
1
Dosage Form
-
Strength
500MG/5ML
Approval Date
2013-02-20
Regulatory Status
RX
Drug Name
SUPRAX
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2012-06-01
Active Ingredient
CEFIXIME
Application Number
203195
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2012-06-01
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-03-26
Active Ingredient
TADALAFIL
Application Number
210567
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
210567
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
210567
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
210567
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-03-26
Regulatory Status
RX
Drug Name
TENOFOVIR ALAFENAMIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2023-03-30
Active Ingredient
TENOFOVIR ALAFENAMIDE FUMARATE
Application Number
214226
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2023-03-30
Regulatory Status
RX
Drug Name
TESTOSTERONE
Product Number
1
Dosage Form
-
Strength
30MG/1.5ML ACTUATION
Approval Date
2017-10-23
Active Ingredient
TESTOSTERONE
Application Number
208061
Product Number
1
Dosage Form
-
Strength
30MG/1.5ML ACTUATION
Approval Date
2017-10-23
Regulatory Status
RX
Drug Name
TESTOSTERONE
Product Number
1
Dosage Form
-
Strength
1.62% (20.25MG/1.25GM ACTUATION)
Approval Date
2019-04-10
Active Ingredient
TESTOSTERONE
Application Number
208560
Product Number
1
Dosage Form
-
Strength
1.62% (20.25MG/1.25GM ACTUATION)
Approval Date
2019-04-10
Regulatory Status
RX
Drug Name
TIOTROPIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.018MG BASE/INH
Approval Date
2023-06-20
Active Ingredient
TIOTROPIUM BROMIDE
Application Number
211287
Product Number
1
Dosage Form
-
Strength
EQ 0.018MG BASE/INH
Approval Date
2023-06-20
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2017-03-22
Active Ingredient
TOBRAMYCIN
Application Number
208964
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2017-03-22
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2025-04-23
Active Ingredient
TOLVAPTAN
Application Number
216063
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2025-04-23
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2025-04-23
Active Ingredient
TOLVAPTAN
Application Number
216063
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2025-04-23
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2025-04-23
Active Ingredient
TOLVAPTAN
Application Number
216063
Product Number
3
Dosage Form
-
Strength
45MG
Approval Date
2025-04-23
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
4
Dosage Form
-
Strength
60MG
Approval Date
2025-04-23
Active Ingredient
TOLVAPTAN
Application Number
216063
Product Number
4
Dosage Form
-
Strength
60MG
Approval Date
2025-04-23
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
5
Dosage Form
-
Strength
90MG
Approval Date
2025-04-23
Active Ingredient
TOLVAPTAN
Application Number
216063
Product Number
5
Dosage Form
-
Strength
90MG
Approval Date
2025-04-23
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2024-07-11
Active Ingredient
TOPIRAMATE
Application Number
215561
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2024-07-11
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2024-07-11
Active Ingredient
TOPIRAMATE
Application Number
215561
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2024-07-11
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2024-07-11
Active Ingredient
TOPIRAMATE
Application Number
215561
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2024-07-11
Regulatory Status
RX
Drug Name
TOPIRAMATE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2024-07-11
Active Ingredient
TOPIRAMATE
Application Number
215561
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2024-07-11
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2011-08-29
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
200503
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2011-08-29
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2011-08-29
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
200503
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2011-08-29
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2011-08-29
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
200503
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2011-08-29
Regulatory Status
RX
Drug Name
TRANDOLAPRIL
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2007-06-12
Active Ingredient
TRANDOLAPRIL
Application Number
77522
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2007-06-12
Regulatory Status
RX
Drug Name
TRANDOLAPRIL
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2007-06-12
Active Ingredient
TRANDOLAPRIL
Application Number
77522
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2007-06-12
Regulatory Status
RX
Drug Name
TRANDOLAPRIL
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2007-06-12
Active Ingredient
TRANDOLAPRIL
Application Number
77522
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2007-06-12
Regulatory Status
RX
Drug Name
TRIMETHOBENZAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2003-08-20
Active Ingredient
TRIMETHOBENZAMIDE HYDROCHLORIDE
Application Number
76546
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2003-08-20
Regulatory Status
RX
Drug Name
TURQOZ
Product Number
1
Dosage Form
-
Strength
0.03MG;0.3MG
Approval Date
2023-07-31
Active Ingredient
ETHINYL ESTRADIOL; NORGESTREL
Application Number
202980
Product Number
1
Dosage Form
-
Strength
0.03MG;0.3MG
Approval Date
2023-07-31
Regulatory Status
RX
Drug Name
TYDEMY
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date
2017-12-12
Active Ingredient
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
Application Number
205948
Product Number
1
Dosage Form
-
Strength
3MG,N/A;0.03MG,N/A;0.451MG,0.451MG
Approval Date
2017-12-12
Regulatory Status
RX
Drug Name
VALBENAZINE TOSYLATE
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-04-05
Active Ingredient
VALBENAZINE TOSYLATE
Application Number
216064
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-04-05
Regulatory Status
RX
Drug Name
VALBENAZINE TOSYLATE
Product Number
2
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-04-05
Active Ingredient
VALBENAZINE TOSYLATE
Application Number
216064
Product Number
2
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-04-05
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2023-12-04
Active Ingredient
VARENICLINE TARTRATE
Application Number
211862
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2023-12-04
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-12-04
Active Ingredient
VARENICLINE TARTRATE
Application Number
211862
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-12-04
Regulatory Status
RX
Drug Name
VYFEMLA
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2013-09-26
Active Ingredient
ETHINYL ESTRADIOL; NORETHINDRONE
Application Number
201886
Product Number
1
Dosage Form
-
Strength
0.035MG;0.4MG
Approval Date
2013-09-26
Regulatory Status
RX
Drug Name
XOPENEX HFA
Product Number
1
Dosage Form
-
Strength
EQ 0.045MG BASE/INH
Approval Date
2005-03-11
Active Ingredient
LEVALBUTEROL TARTRATE
Application Number
21730
Product Number
1
Dosage Form
-
Strength
EQ 0.045MG BASE/INH
Approval Date
2005-03-11
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
1
Dosage Form
-
Strength
6.25MG
Approval Date
2013-09-11
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
78970
Product Number
1
Dosage Form
-
Strength
6.25MG
Approval Date
2013-09-11
Regulatory Status
RX
Drug Name
ZOLPIDEM TARTRATE
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
2013-09-11
Active Ingredient
ZOLPIDEM TARTRATE
Application Number
78970
Product Number
2
Dosage Form
-
Strength
12.5MG
Approval Date
2013-09-11
Regulatory Status
RX
Drug Status Breakdown
333 total- RX
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
ALBUTEROL SULFATE
Application Number
209954
Product Number
1
Active Ingredient
ALBUTEROL SULFATE
Dosage Form
-
Strength
EQ 0.09MG BASE/INH
FDA Approved Drug Data
Approved drug product information
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