Macleods Pharmaceuticals Limited
FDA Approved Drugs
Macleods 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 427
- Latest Approval Date Aug 03, 2026
- Data Source FDA
- First Approval Date Jan 12, 2012
Company Overview
Company
Macleods Pharmaceuticals Limited
Country
India
Website
Social Profiles
Company Snapshot
Macleods Pharmaceuticals Limited
Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai - 400059
India
www.macleodspharma.com/ exports@macleodspharma.com View on MapFDA Approved Drug Records ( 427 records )
Drug Name
ABACAVIR SULFATE AND LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE;300MG
Approval Date
2024-12-19
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Application Number
212663
Product Number
1
Dosage Form
-
Strength
EQ 600MG BASE;300MG
Approval Date
2024-12-19
Regulatory Status
Discontinued
Drug Name
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
Application Number
217830
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
-
Active Ingredient
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE
Application Number
217830
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2021-05-19
Active Ingredient
ACYCLOVIR
Application Number
212444
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2021-05-19
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206884
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2016-10-26
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206884
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2016-10-26
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206884
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2016-10-26
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2016-10-26
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
206884
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2016-10-26
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2024-10-11
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
207292
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;160MG
Approval Date
2024-10-11
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2024-10-11
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
207292
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE;160MG
Approval Date
2024-10-11
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2024-10-11
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
207292
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;320MG
Approval Date
2024-10-11
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE AND VALSARTAN
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2024-10-11
Active Ingredient
AMLODIPINE BESYLATE; VALSARTAN
Application Number
207292
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;320MG
Approval Date
2024-10-11
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;160MG
Approval Date
2025-01-07
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
207299
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;160MG
Approval Date
2025-01-07
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;25MG;160MG
Approval Date
2025-01-07
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
207299
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;25MG;160MG
Approval Date
2025-01-07
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;160MG
Approval Date
2025-01-07
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
207299
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;160MG
Approval Date
2025-01-07
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;25MG;160MG
Approval Date
2025-01-07
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
207299
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;25MG;160MG
Approval Date
2025-01-07
Regulatory Status
RX
Drug Name
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;320MG
Approval Date
2025-01-07
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
207299
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;320MG
Approval Date
2025-01-07
Regulatory Status
RX
Drug Name
APIXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-02-27
Active Ingredient
APIXABAN
Application Number
210067
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-02-27
Regulatory Status
Discontinued
Drug Name
APIXABAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2025-02-27
Active Ingredient
APIXABAN
Application Number
210067
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2025-02-27
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-11-25
Active Ingredient
APREMILAST
Application Number
211788
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-11-25
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-11-25
Active Ingredient
APREMILAST
Application Number
211788
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-11-25
Regulatory Status
Discontinued
Drug Name
APREMILAST
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-11-25
Active Ingredient
APREMILAST
Application Number
211788
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-11-25
Regulatory Status
Discontinued
Drug Name
ARIPIPRAZOLE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2016-10-07
Active Ingredient
ARIPIPRAZOLE
Application Number
204111
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2016-10-07
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2016-10-07
Active Ingredient
ARIPIPRAZOLE
Application Number
204111
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2016-10-07
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2016-10-07
Active Ingredient
ARIPIPRAZOLE
Application Number
204111
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2016-10-07
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2016-10-07
Active Ingredient
ARIPIPRAZOLE
Application Number
204111
Product Number
4
Dosage Form
-
Strength
15MG
Approval Date
2016-10-07
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2016-10-07
Active Ingredient
ARIPIPRAZOLE
Application Number
204111
Product Number
5
Dosage Form
-
Strength
20MG
Approval Date
2016-10-07
Regulatory Status
RX
Drug Name
ARIPIPRAZOLE
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2016-10-07
Active Ingredient
ARIPIPRAZOLE
Application Number
204111
Product Number
6
Dosage Form
-
Strength
30MG
Approval Date
2016-10-07
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-06-03
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
208480
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-06-03
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-06-03
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
208480
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-06-03
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-06-03
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
208480
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-06-03
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-06-03
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
208480
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-06-03
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2026-06-23
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
218567
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2026-06-23
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2026-06-23
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
218567
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2026-06-23
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2026-06-23
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
218567
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2026-06-23
Regulatory Status
RX
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1000MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN
Application Number
215255
Product Number
1
Dosage Form
-
Strength
1000MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN
Application Number
215255
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN
Application Number
215255
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE; CANAGLIFLOZIN
Application Number
215255
Product Number
4
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CANDESARTAN CILEXETIL
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2016-12-05
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
203813
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2016-12-05
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2016-12-05
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
203813
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2016-12-05
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2016-12-05
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
203813
Product Number
3
Dosage Form
-
Strength
16MG
Approval Date
2016-12-05
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL
Product Number
4
Dosage Form
-
Strength
32MG
Approval Date
2016-12-05
Active Ingredient
CANDESARTAN CILEXETIL
Application Number
203813
Product Number
4
Dosage Form
-
Strength
32MG
Approval Date
2016-12-05
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
16MG;12.5MG
Approval Date
2015-02-27
Active Ingredient
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Application Number
204100
Product Number
1
Dosage Form
-
Strength
16MG;12.5MG
Approval Date
2015-02-27
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
32MG;12.5MG
Approval Date
2015-02-27
Active Ingredient
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Application Number
204100
Product Number
2
Dosage Form
-
Strength
32MG;12.5MG
Approval Date
2015-02-27
Regulatory Status
RX
Drug Name
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
32MG;25MG
Approval Date
2015-02-27
Active Ingredient
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
Application Number
204100
Product Number
3
Dosage Form
-
Strength
32MG;25MG
Approval Date
2015-02-27
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
1
Dosage Form
-
Strength
12.5MG;200MG;50MG
Approval Date
2025-04-15
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
214495
Product Number
1
Dosage Form
-
Strength
12.5MG;200MG;50MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
2
Dosage Form
-
Strength
18.75MG;200MG;75MG
Approval Date
2025-04-15
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
214495
Product Number
2
Dosage Form
-
Strength
18.75MG;200MG;75MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
3
Dosage Form
-
Strength
25MG;200MG;100MG
Approval Date
2025-04-15
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
214495
Product Number
3
Dosage Form
-
Strength
25MG;200MG;100MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
4
Dosage Form
-
Strength
31.25MG;200MG;125MG
Approval Date
2025-04-15
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
214495
Product Number
4
Dosage Form
-
Strength
31.25MG;200MG;125MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
5
Dosage Form
-
Strength
37.5MG;200MG;150MG
Approval Date
2025-04-15
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
214495
Product Number
5
Dosage Form
-
Strength
37.5MG;200MG;150MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
CARBIDOPA, LEVODOPA AND ENTACAPONE
Product Number
6
Dosage Form
-
Strength
50MG;200MG;200MG
Approval Date
2025-04-15
Active Ingredient
CARBIDOPA; ENTACAPONE; LEVODOPA
Application Number
214495
Product Number
6
Dosage Form
-
Strength
50MG;200MG;200MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2016-03-16
Active Ingredient
CELECOXIB
Application Number
204590
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2016-03-16
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2016-03-16
Active Ingredient
CELECOXIB
Application Number
204590
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2016-03-16
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2016-03-16
Active Ingredient
CELECOXIB
Application Number
204590
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2016-03-16
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2016-03-16
Active Ingredient
CELECOXIB
Application Number
204590
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2016-03-16
Regulatory Status
RX
Drug Name
CEVIMELINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2024-09-20
Active Ingredient
CEVIMELINE HYDROCHLORIDE
Application Number
206808
Product Number
1
Dosage Form
-
Strength
30MG
Approval Date
2024-09-20
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-07-01
Active Ingredient
CHLORTHALIDONE
Application Number
212229
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2026-07-01
Active Ingredient
CHLORTHALIDONE
Application Number
212229
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
CHOLESTYRAMINE
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/PACKET
Approval Date
2024-11-21
Active Ingredient
CHOLESTYRAMINE
Application Number
207294
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/PACKET
Approval Date
2024-11-21
Regulatory Status
RX
Drug Name
CHOLESTYRAMINE
Product Number
2
Dosage Form
-
Strength
EQ 4GM RESIN/SCOOPFUL
Approval Date
2024-11-21
Active Ingredient
CHOLESTYRAMINE
Application Number
207294
Product Number
2
Dosage Form
-
Strength
EQ 4GM RESIN/SCOOPFUL
Approval Date
2024-11-21
Regulatory Status
RX
Drug Name
CHOLESTYRAMINE LIGHT
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/SCOOPFUL
Approval Date
2024-10-31
Active Ingredient
CHOLESTYRAMINE
Application Number
209109
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/SCOOPFUL
Approval Date
2024-10-31
Regulatory Status
Discontinued
Drug Name
CHOLESTYRAMINE LIGHT
Product Number
2
Dosage Form
-
Strength
EQ 4GM RESIN/PACKET
Approval Date
2024-10-31
Active Ingredient
CHOLESTYRAMINE
Application Number
209109
Product Number
2
Dosage Form
-
Strength
EQ 4GM RESIN/PACKET
Approval Date
2024-10-31
Regulatory Status
Discontinued
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2017-10-25
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
209361
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2017-10-25
Regulatory Status
RX
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2024-12-02
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
214345
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2024-12-02
Regulatory Status
Discontinued
Drug Name
CLOBETASOL PROPIONATE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2023-12-28
Active Ingredient
CLOBETASOL PROPIONATE
Application Number
215990
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2023-12-28
Regulatory Status
RX
Drug Name
CLOPIDOGREL BISULFATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2014-02-10
Active Ingredient
CLOPIDOGREL BISULFATE
Application Number
202928
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2014-02-10
Regulatory Status
RX
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2026-02-13
Active Ingredient
COLCHICINE
Application Number
210633
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2026-02-13
Regulatory Status
RX
Drug Name
COLESEVELAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
625MG
Approval Date
2025-04-18
Active Ingredient
COLESEVELAM HYDROCHLORIDE
Application Number
204893
Product Number
1
Dosage Form
-
Strength
625MG
Approval Date
2025-04-18
Regulatory Status
Discontinued
Drug Name
CRISABOROLE
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
-
Active Ingredient
CRISABOROLE
Application Number
216242
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
-
Regulatory Status
Unclassified
Drug Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2024-07-22
Active Ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Application Number
207314
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2024-07-22
Regulatory Status
RX
Drug Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2024-07-22
Active Ingredient
CYCLOBENZAPRINE HYDROCHLORIDE
Application Number
207314
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2024-07-22
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211506
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
211506
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
211559
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
211559
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
211559
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
211559
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-07-08
Active Ingredient
DAPSONE
Application Number
218335
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2026-07-08
Regulatory Status
RX
Drug Name
DAPSONE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2026-07-08
Active Ingredient
DAPSONE
Application Number
218335
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2026-07-08
Regulatory Status
RX
Drug Name
DARIFENACIN
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2017-07-28
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
207302
Product Number
1
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2017-07-28
Regulatory Status
RX
Drug Name
DARIFENACIN
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2017-07-28
Active Ingredient
DARIFENACIN HYDROBROMIDE
Application Number
207302
Product Number
2
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2017-07-28
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2025-01-15
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
211427
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2025-01-15
Regulatory Status
RX
Drug Name
DESVENLAFAXINE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-01-15
Active Ingredient
DESVENLAFAXINE SUCCINATE
Application Number
211427
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-01-15
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2026-02-27
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218744
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2026-02-27
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2026-02-27
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218744
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2026-02-27
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
2026-02-27
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218744
Product Number
3
Dosage Form
-
Strength
240MG
Approval Date
2026-02-27
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2026-02-27
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218744
Product Number
4
Dosage Form
-
Strength
300MG
Approval Date
2026-02-27
Regulatory Status
RX
Drug Name
DILTIAZEM HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
360MG
Approval Date
2026-02-27
Active Ingredient
DILTIAZEM HYDROCHLORIDE
Application Number
218744
Product Number
5
Dosage Form
-
Strength
360MG
Approval Date
2026-02-27
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2024-06-26
Active Ingredient
DIMETHYL FUMARATE
Application Number
210377
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2024-06-26
Active Ingredient
DIMETHYL FUMARATE
Application Number
210377
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
DOLUTEGRAVIR SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
-
Active Ingredient
DOLUTEGRAVIR SODIUM
Application Number
214397
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOLUTEGRAVIR SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Active Ingredient
DOLUTEGRAVIR SODIUM
Application Number
214397
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOLUTEGRAVIR SODIUM
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
-
Active Ingredient
DOLUTEGRAVIR SODIUM
Application Number
214397
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOLUTEGRAVIR SODIUM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR SODIUM
Application Number
214566
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
50MG/300MG/300MG
Approval Date
-
Active Ingredient
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
Application Number
210796
Product Number
1
Dosage Form
-
Strength
50MG/300MG/300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2012-08-17
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
201146
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2012-08-17
Regulatory Status
RX
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2012-08-17
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
201146
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2012-08-17
Regulatory Status
RX
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2012-12-14
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
201787
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2012-12-14
Regulatory Status
RX
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2012-12-14
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
201787
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2012-12-14
Regulatory Status
RX
Drug Name
DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
23MG
Approval Date
2014-01-22
Active Ingredient
DONEPEZIL HYDROCHLORIDE
Application Number
202631
Product Number
1
Dosage Form
-
Strength
23MG
Approval Date
2014-01-22
Regulatory Status
RX
Drug Name
DOXYCYCLINE
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2025-03-27
Active Ingredient
DOXYCYCLINE
Application Number
210381
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2025-03-27
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-12-09
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
211137
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-12-09
Regulatory Status
RX
Drug Name
DOXYCYCLINE HYCLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-11-19
Active Ingredient
DOXYCYCLINE HYCLATE
Application Number
211418
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2025-11-19
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-03-23
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
204815
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-03-23
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2017-03-23
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
204815
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2017-03-23
Regulatory Status
RX
Drug Name
DULOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2017-03-23
Active Ingredient
DULOXETINE HYDROCHLORIDE
Application Number
204815
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2017-03-23
Regulatory Status
RX
Drug Name
EFAVIRENZ
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2024-05-10
Active Ingredient
EFAVIRENZ
Application Number
91579
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2024-05-10
Regulatory Status
RX
Drug Name
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG;200MG;300MG
Approval Date
2021-09-13
Active Ingredient
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
204287
Product Number
1
Dosage Form
-
Strength
600MG;200MG;300MG
Approval Date
2021-09-13
Regulatory Status
RX
Drug Name
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
400MG;300MG;300MG
Approval Date
2019-03-15
Active Ingredient
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
210649
Product Number
1
Dosage Form
-
Strength
400MG;300MG;300MG
Approval Date
2019-03-15
Regulatory Status
Discontinued
Drug Name
EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
-
Active Ingredient
EFAVIRENZ;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
Application Number
205861
Product Number
1
Dosage Form
-
Strength
600MG;300MG;300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG;500MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
Application Number
212373
Product Number
1
Dosage Form
-
Strength
5MG;500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG;1000MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
Application Number
212373
Product Number
2
Dosage Form
-
Strength
5MG;1000MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
12.5MG;500MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
Application Number
212373
Product Number
3
Dosage Form
-
Strength
12.5MG;500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
12.5MG;1000MG
Approval Date
-
Active Ingredient
EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE
Application Number
212373
Product Number
4
Dosage Form
-
Strength
12.5MG;1000MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG;EQ 25MG BASE
Approval Date
2026-04-07
Active Ingredient
EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Application Number
214216
Product Number
1
Dosage Form
-
Strength
200MG;EQ 25MG BASE
Approval Date
2026-04-07
Regulatory Status
RX
Drug Name
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
200MG;300MG
Approval Date
2020-05-15
Active Ingredient
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
203442
Product Number
1
Dosage Form
-
Strength
200MG;300MG
Approval Date
2020-05-15
Regulatory Status
RX
Drug Name
ENTACAPONE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2017-06-05
Active Ingredient
ENTACAPONE
Application Number
207210
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2017-06-05
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
202210
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2012-09-11
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
202210
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2012-09-11
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-09-11
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
202210
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-09-11
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/5ML
Approval Date
2016-03-31
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
202754
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE/5ML
Approval Date
2016-03-31
Regulatory Status
RX
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-10-23
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
208511
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-10-23
Regulatory Status
Discontinued
Drug Name
ESOMEPRAZOLE MAGNESIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-10-23
Active Ingredient
ESOMEPRAZOLE MAGNESIUM
Application Number
208511
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-10-23
Regulatory Status
Discontinued
Drug Name
ESZOPICLONE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2015-01-30
Active Ingredient
ESZOPICLONE
Application Number
202929
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2015-01-30
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2015-01-30
Active Ingredient
ESZOPICLONE
Application Number
202929
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2015-01-30
Regulatory Status
RX
Drug Name
ESZOPICLONE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2015-01-30
Active Ingredient
ESZOPICLONE
Application Number
202929
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2015-01-30
Regulatory Status
RX
Drug Name
EZETIMIBE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-04-29
Active Ingredient
EZETIMIBE
Application Number
211159
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-04-29
Regulatory Status
Discontinued
Drug Name
FAMCICLOVIR
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2012-01-12
Active Ingredient
FAMCICLOVIR
Application Number
201022
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2012-01-12
Regulatory Status
RX
Drug Name
FAMCICLOVIR
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2012-01-12
Active Ingredient
FAMCICLOVIR
Application Number
201022
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2012-01-12
Regulatory Status
RX
Drug Name
FAMCICLOVIR
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2012-01-12
Active Ingredient
FAMCICLOVIR
Application Number
201022
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2012-01-12
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2023-09-28
Active Ingredient
FEBUXOSTAT
Application Number
207293
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2023-09-28
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2023-09-28
Active Ingredient
FEBUXOSTAT
Application Number
207293
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2023-09-28
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2024-11-13
Active Ingredient
FENOFIBRATE
Application Number
210248
Product Number
1
Dosage Form
-
Strength
48MG
Approval Date
2024-11-13
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2024-11-13
Active Ingredient
FENOFIBRATE
Application Number
210248
Product Number
2
Dosage Form
-
Strength
145MG
Approval Date
2024-11-13
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2026-01-21
Active Ingredient
FENOFIBRATE
Application Number
210379
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2026-01-21
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2026-01-21
Active Ingredient
FENOFIBRATE
Application Number
210379
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2026-01-21
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2024-02-08
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
207796
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2024-02-08
Regulatory Status
Discontinued
Drug Name
FENOFIBRIC ACID
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2024-02-08
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
207796
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2024-02-08
Regulatory Status
Discontinued
Drug Name
FLUOCINONIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2018-04-23
Active Ingredient
FLUOCINONIDE
Application Number
209283
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2018-04-23
Regulatory Status
RX
Drug Name
HYDRALAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-08-21
Active Ingredient
HYDRALAZINE HYDROCHLORIDE
Application Number
211010
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-08-21
Regulatory Status
Discontinued
Drug Name
HYDRALAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2024-08-21
Active Ingredient
HYDRALAZINE HYDROCHLORIDE
Application Number
211010
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2024-08-21
Regulatory Status
Discontinued
Drug Name
HYDRALAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2024-08-21
Active Ingredient
HYDRALAZINE HYDROCHLORIDE
Application Number
211010
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2024-08-21
Regulatory Status
Discontinued
Drug Name
HYDRALAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2024-08-21
Active Ingredient
HYDRALAZINE HYDROCHLORIDE
Application Number
211010
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2024-08-21
Regulatory Status
Discontinued
Drug Name
IBANDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-10-31
Active Ingredient
IBANDRONATE SODIUM
Application Number
206887
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-10-31
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-10-03
Active Ingredient
IRBESARTAN
Application Number
202254
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2012-10-03
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-10-03
Active Ingredient
IRBESARTAN
Application Number
202254
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2012-10-03
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-10-03
Active Ingredient
IRBESARTAN
Application Number
202254
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2012-10-03
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2012-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
202414
Product Number
1
Dosage Form
-
Strength
12.5MG;150MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2012-09-27
Active Ingredient
HYDROCHLOROTHIAZIDE; IRBESARTAN
Application Number
202414
Product Number
2
Dosage Form
-
Strength
12.5MG;300MG
Approval Date
2012-09-27
Regulatory Status
RX
Drug Name
IRBESARTAN; HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
300MG; 25MG
Approval Date
-
Active Ingredient
IRBESARTAN: HYDROCHLOROTHIAZIDE
Application Number
202414
Product Number
3
Dosage Form
-
Strength
300MG; 25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LABETALOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-09-23
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
217949
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-09-23
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-09-23
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
217949
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-09-23
Regulatory Status
RX
Drug Name
LABETALOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-09-23
Active Ingredient
LABETALOL HYDROCHLORIDE
Application Number
217949
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-09-23
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2024-05-24
Active Ingredient
LACOSAMIDE
Application Number
208466
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2024-05-24
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2024-05-24
Active Ingredient
LACOSAMIDE
Application Number
208466
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2024-05-24
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2024-05-24
Active Ingredient
LACOSAMIDE
Application Number
208466
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2024-05-24
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2024-05-24
Active Ingredient
LACOSAMIDE
Application Number
208466
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2024-05-24
Regulatory Status
RX
Drug Name
LAMIVUDINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2019-05-01
Active Ingredient
LAMIVUDINE
Application Number
90198
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2019-05-01
Regulatory Status
RX
Drug Name
LAMIVUDINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2019-05-01
Active Ingredient
LAMIVUDINE
Application Number
90198
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2019-05-01
Regulatory Status
RX
Drug Name
LAMIVUDINE AND STAVUDINE
Product Number
1
Dosage Form
-
Strength
150MG; 30MG
Approval Date
-
Active Ingredient
LAMIVUDINE; STAVUDINE
Application Number
22541
Product Number
1
Dosage Form
-
Strength
150MG; 30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE AND ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
150MG;300MG
Approval Date
2018-08-29
Active Ingredient
LAMIVUDINE; ZIDOVUDINE
Application Number
90679
Product Number
1
Dosage Form
-
Strength
150MG;300MG
Approval Date
2018-08-29
Regulatory Status
RX
Drug Name
LAMIVUDINE, NEVIRAPINE, AND STAVUDINE
Product Number
1
Dosage Form
-
Strength
150MG;200MG;30MG
Approval Date
-
Active Ingredient
LAMIVUDINE, NEVIRAPINE, AND STAVUDINE
Application Number
22537
Product Number
1
Dosage Form
-
Strength
150MG;200MG;30MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
Product Number
1
Dosage Form
-
Strength
150MG; 200MG; 300MG
Approval Date
-
Active Ingredient
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE
Application Number
202589
Product Number
1
Dosage Form
-
Strength
150MG; 200MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
300MG; 300MG
Approval Date
-
Active Ingredient
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Application Number
203283
Product Number
1
Dosage Form
-
Strength
300MG; 300MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
LANSOPRAZOLE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2024-11-04
Active Ingredient
LANSOPRAZOLE
Application Number
208671
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2024-11-04
Regulatory Status
Discontinued
Drug Name
LANSOPRAZOLE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2024-11-04
Active Ingredient
LANSOPRAZOLE
Application Number
208671
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2024-11-04
Regulatory Status
Discontinued
Drug Name
LEVOCETIRIZINE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2016-01-11
Active Ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Application Number
205564
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2016-01-11
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2012-03-22
Active Ingredient
LEVOFLOXACIN
Application Number
200839
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2012-03-22
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2012-03-22
Active Ingredient
LEVOFLOXACIN
Application Number
200839
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2012-03-22
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2012-03-22
Active Ingredient
LEVOFLOXACIN
Application Number
200839
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2012-03-22
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
1
Dosage Form
-
Strength
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
2
Dosage Form
-
Strength
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
3
Dosage Form
-
Strength
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
4
Dosage Form
-
Strength
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
5
Dosage Form
-
Strength
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
6
Dosage Form
-
Strength
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
7
Dosage Form
-
Strength
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
8
Dosage Form
-
Strength
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
9
Dosage Form
-
Strength
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
10
Dosage Form
-
Strength
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
11
Dosage Form
-
Strength
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
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
2022-12-21
Active Ingredient
LEVOTHYROXINE SODIUM
Application Number
211417
Product Number
12
Dosage Form
-
Strength
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
Approval Date
2022-12-21
Regulatory Status
RX
Drug Name
LIDOCAINE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2020-03-16
Active Ingredient
LIDOCAINE
Application Number
211697
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2020-03-16
Regulatory Status
RX
Drug Name
LINEZOLID
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2024-10-10
Active Ingredient
LINEZOLID
Application Number
210378
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2024-10-10
Regulatory Status
Discontinued
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2024-07-25
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
204739
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2024-07-25
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2024-07-25
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
204739
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2024-07-25
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2012-05-30
Active Ingredient
LOSARTAN POTASSIUM
Application Number
202230
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2012-05-30
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2012-05-30
Active Ingredient
LOSARTAN POTASSIUM
Application Number
202230
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2012-05-30
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2012-05-30
Active Ingredient
LOSARTAN POTASSIUM
Application Number
202230
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2012-05-30
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2012-08-09
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
202289
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
2012-08-09
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2012-08-09
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
202289
Product Number
2
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2012-08-09
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2012-08-09
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
202289
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
2012-08-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-06-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
212124
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-06-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2023-06-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
212124
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2023-06-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2023-06-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
212124
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2023-06-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2023-06-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
212124
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2023-06-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2023-06-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
212124
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2023-06-09
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2015-10-13
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
202790
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2015-10-13
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
202840
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
202840
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-10-13
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2025-08-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206310
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2025-08-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2025-08-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206310
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2025-08-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
21MG
Approval Date
2025-08-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206310
Product Number
3
Dosage Form
-
Strength
21MG
Approval Date
2025-08-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
28MG
Approval Date
2025-08-28
Active Ingredient
MEMANTINE HYDROCHLORIDE
Application Number
206310
Product Number
4
Dosage Form
-
Strength
28MG
Approval Date
2025-08-28
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;14MG
Approval Date
2025-07-15
Active Ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Application Number
208672
Product Number
1
Dosage Form
-
Strength
10MG;14MG
Approval Date
2025-07-15
Regulatory Status
RX
Drug Name
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG;28MG
Approval Date
2025-07-15
Active Ingredient
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Application Number
208672
Product Number
2
Dosage Form
-
Strength
10MG;28MG
Approval Date
2025-07-15
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2016-12-07
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
206955
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2016-12-07
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2016-12-07
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
206955
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2016-12-07
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2024-03-13
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
211163
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2024-03-13
Regulatory Status
Discontinued
Drug Name
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE || SITAGLIPTIN
Application Number
212338
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE || SITAGLIPTIN
Application Number
212338
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE
Product Number
3
Dosage Form
-
Strength
1000MG
Approval Date
-
Active Ingredient
METFORMIN HYDROCHLORIDE || SITAGLIPTIN
Application Number
212338
Product Number
3
Dosage Form
-
Strength
1000MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
METHIMAZOLE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-05-24
Active Ingredient
METHIMAZOLE
Application Number
209827
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-05-24
Regulatory Status
RX
Drug Name
METHIMAZOLE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2023-05-24
Active Ingredient
METHIMAZOLE
Application Number
209827
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2023-05-24
Regulatory Status
RX
Drug Name
MEXILETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2026-03-23
Active Ingredient
MEXILETINE HYDROCHLORIDE
Application Number
219987
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2026-03-23
Regulatory Status
RX
Drug Name
MEXILETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2026-03-23
Active Ingredient
MEXILETINE HYDROCHLORIDE
Application Number
219987
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2026-03-23
Regulatory Status
RX
Drug Name
MEXILETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2026-03-23
Active Ingredient
MEXILETINE HYDROCHLORIDE
Application Number
219987
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2026-03-23
Regulatory Status
RX
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
210944
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
210944
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
210944
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MILNACIPRAN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
MILNACIPRAN HYDROCHLORIDE
Application Number
210944
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2014-09-11
Active Ingredient
MONTELUKAST SODIUM
Application Number
203366
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2014-09-11
Regulatory Status
RX
Drug Name
MONTELUKAST SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2015-03-12
Active Ingredient
MONTELUKAST SODIUM
Application Number
203582
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2015-03-12
Regulatory Status
RX
Drug Name
MONTELUKAST SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2015-03-12
Active Ingredient
MONTELUKAST SODIUM
Application Number
203582
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2015-03-12
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2026-03-02
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
209143
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2026-03-02
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2025-01-28
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
212661
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2025-01-28
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2025-01-28
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
212661
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2025-01-28
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2025-01-28
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
212661
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2025-01-28
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2025-01-28
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
212661
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2025-01-28
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2019-01-14
Active Ingredient
NEVIRAPINE
Application Number
90688
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2019-01-14
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2017-10-06
Active Ingredient
NEVIRAPINE
Application Number
206879
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2017-10-06
Regulatory Status
RX
Drug Name
NIACIN
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-03-03
Active Ingredient
NIACIN
Application Number
204934
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2022-03-03
Regulatory Status
RX
Drug Name
NIACIN
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2022-03-03
Active Ingredient
NIACIN
Application Number
204934
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2022-03-03
Regulatory Status
RX
Drug Name
NINTEDANIB ESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-08-03
Active Ingredient
NINTEDANIB ESYLATE
Application Number
219926
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-08-03
Regulatory Status
RX
Drug Name
NINTEDANIB ESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-08-03
Active Ingredient
NINTEDANIB ESYLATE
Application Number
219926
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-08-03
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2021-08-10
Active Ingredient
NYSTATIN
Application Number
213566
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2021-08-10
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2021-01-14
Active Ingredient
NYSTATIN
Application Number
213826
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM
Approval Date
2021-01-14
Regulatory Status
RX
Drug Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2022-07-13
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
214181
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2022-07-13
Regulatory Status
RX
Drug Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2021-08-17
Active Ingredient
NYSTATIN; TRIAMCINOLONE ACETONIDE
Application Number
214751
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/GM;0.1%
Approval Date
2021-08-17
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2014-08-15
Active Ingredient
OLANZAPINE
Application Number
202862
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2014-08-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2014-08-15
Active Ingredient
OLANZAPINE
Application Number
202862
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2014-08-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2014-08-15
Active Ingredient
OLANZAPINE
Application Number
202862
Product Number
3
Dosage Form
-
Strength
7.5MG
Approval Date
2014-08-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2014-08-15
Active Ingredient
OLANZAPINE
Application Number
202862
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2014-08-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2014-08-15
Active Ingredient
OLANZAPINE
Application Number
202862
Product Number
5
Dosage Form
-
Strength
15MG
Approval Date
2014-08-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2014-08-15
Active Ingredient
OLANZAPINE
Application Number
202862
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2014-08-15
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-02-20
Active Ingredient
OLANZAPINE
Application Number
203044
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-02-20
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-02-20
Active Ingredient
OLANZAPINE
Application Number
203044
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2015-02-20
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2015-02-20
Active Ingredient
OLANZAPINE
Application Number
203044
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2015-02-20
Regulatory Status
RX
Drug Name
OLANZAPINE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2015-02-20
Active Ingredient
OLANZAPINE
Application Number
203044
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2015-02-20
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
204814
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
204814
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
204814
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
2023-06-01
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
204801
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2023-06-01
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2023-06-01
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
204801
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2023-06-01
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2023-06-01
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
204801
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2023-06-01
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;20MG
Approval Date
2025-07-18
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207088
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;20MG
Approval Date
2025-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;40MG
Approval Date
2025-07-18
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207088
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;40MG
Approval Date
2025-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;25MG;40MG
Approval Date
2025-07-18
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207088
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;25MG;40MG
Approval Date
2025-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;40MG
Approval Date
2025-07-18
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207088
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;40MG
Approval Date
2025-07-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;40MG
Approval Date
2025-07-18
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207088
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;40MG
Approval Date
2025-07-18
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2017-09-14
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
207211
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2017-09-14
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2017-09-14
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
207211
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2017-09-14
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-09-14
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
207211
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-09-14
Regulatory Status
RX
Drug Name
OXCARBAZEPINE
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2025-07-11
Active Ingredient
OXCARBAZEPINE
Application Number
207300
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2025-07-11
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-02-16
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
200821
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2012-02-16
Regulatory Status
Discontinued
Drug Name
PANTOPRAZOLE SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-02-16
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
200821
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2012-02-16
Regulatory Status
Discontinued
Drug Name
PERPHENAZINE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2024-05-06
Active Ingredient
PERPHENAZINE
Application Number
212545
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2024-05-06
Active Ingredient
PERPHENAZINE
Application Number
212545
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
2024-05-06
Active Ingredient
PERPHENAZINE
Application Number
212545
Product Number
3
Dosage Form
-
Strength
8MG
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
PERPHENAZINE
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
2024-05-06
Active Ingredient
PERPHENAZINE
Application Number
212545
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2013-02-06
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
202467
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2013-02-06
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-02-06
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
202467
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2013-02-06
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2013-02-06
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
202467
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2013-02-06
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG;EQ 15MG BASE
Approval Date
2015-11-05
Active Ingredient
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Application Number
204802
Product Number
1
Dosage Form
-
Strength
500MG;EQ 15MG BASE
Approval Date
2015-11-05
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
850MG;EQ 15MG BASE
Approval Date
2015-11-05
Active Ingredient
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Application Number
204802
Product Number
2
Dosage Form
-
Strength
850MG;EQ 15MG BASE
Approval Date
2015-11-05
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2024-12-18
Active Ingredient
PIRFENIDONE
Application Number
212748
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2024-12-18
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
8MEQ
Approval Date
2024-09-06
Active Ingredient
POTASSIUM CHLORIDE
Application Number
212987
Product Number
1
Dosage Form
-
Strength
8MEQ
Approval Date
2024-09-06
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
10MEQ
Approval Date
2024-09-06
Active Ingredient
POTASSIUM CHLORIDE
Application Number
212987
Product Number
2
Dosage Form
-
Strength
10MEQ
Approval Date
2024-09-06
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
10MEQ
Approval Date
2024-05-09
Active Ingredient
POTASSIUM CHLORIDE
Application Number
216269
Product Number
1
Dosage Form
-
Strength
10MEQ
Approval Date
2024-05-09
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
15MEQ
Approval Date
2024-05-09
Active Ingredient
POTASSIUM CHLORIDE
Application Number
216269
Product Number
2
Dosage Form
-
Strength
15MEQ
Approval Date
2024-05-09
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
3
Dosage Form
-
Strength
20MEQ
Approval Date
2024-05-09
Active Ingredient
POTASSIUM CHLORIDE
Application Number
216269
Product Number
3
Dosage Form
-
Strength
20MEQ
Approval Date
2024-05-09
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MEQ/15ML
Approval Date
2025-09-10
Active Ingredient
POTASSIUM CHLORIDE
Application Number
218733
Product Number
1
Dosage Form
-
Strength
20MEQ/15ML
Approval Date
2025-09-10
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
40MEQ/15ML
Approval Date
2025-09-10
Active Ingredient
POTASSIUM CHLORIDE
Application Number
218733
Product Number
2
Dosage Form
-
Strength
40MEQ/15ML
Approval Date
2025-09-10
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2012-09-20
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202164
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2012-09-20
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2012-09-20
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202164
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2012-09-20
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2012-09-20
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202164
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2012-09-20
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2012-09-20
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202164
Product Number
4
Dosage Form
-
Strength
1MG
Approval Date
2012-09-20
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
2012-09-20
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
202164
Product Number
5
Dosage Form
-
Strength
1.5MG
Approval Date
2012-09-20
Regulatory Status
Discontinued
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.375MG
Approval Date
2016-06-24
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
1
Dosage Form
-
Strength
0.375MG
Approval Date
2016-06-24
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
0.75MG
Approval Date
2016-06-24
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
2
Dosage Form
-
Strength
0.75MG
Approval Date
2016-06-24
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2016-06-24
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2016-06-24
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
2.25MG
Approval Date
2016-06-24
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
4
Dosage Form
-
Strength
2.25MG
Approval Date
2016-06-24
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2016-06-24
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
5
Dosage Form
-
Strength
3MG
Approval Date
2016-06-24
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
4.5MG
Approval Date
2016-06-24
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
6
Dosage Form
-
Strength
4.5MG
Approval Date
2016-06-24
Regulatory Status
RX
Drug Name
PRAMIPEXOLE DIHYDROCHLORIDE
Product Number
7
Dosage Form
-
Strength
3.75MG
Approval Date
2017-01-23
Active Ingredient
PRAMIPEXOLE DIHYDROCHLORIDE
Application Number
206156
Product Number
7
Dosage Form
-
Strength
3.75MG
Approval Date
2017-01-23
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PREGABALIN
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2024-11-12
Active Ingredient
PREGABALIN
Application Number
205924
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2024-11-12
Regulatory Status
Discontinued
Drug Name
PROPYLTHIOURACIL
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2023-05-10
Active Ingredient
PROPYLTHIOURACIL
Application Number
208867
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2023-05-10
Regulatory Status
RX
Drug Name
PYRAZINAMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-07-27
Active Ingredient
PYRAZINAMIDE
Application Number
212541
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-07-27
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2016-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203359
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2016-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2016-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203359
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2016-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2016-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203359
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2016-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2016-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203359
Product Number
4
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2016-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2016-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203359
Product Number
5
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2016-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2016-05-17
Active Ingredient
QUETIAPINE FUMARATE
Application Number
203359
Product Number
6
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2016-05-17
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204253
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204253
Product Number
2
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204253
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
QUETIAPINE FUMARATE
Product Number
4
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-11-29
Active Ingredient
QUETIAPINE FUMARATE
Application Number
204253
Product Number
4
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-11-29
Regulatory Status
RX
Drug Name
RASAGILINE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-06-28
Active Ingredient
RASAGILINE MESYLATE
Application Number
208866
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-06-28
Regulatory Status
RX
Drug Name
RASAGILINE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-06-28
Active Ingredient
RASAGILINE MESYLATE
Application Number
208866
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-06-28
Regulatory Status
RX
Drug Name
REPAGLINIDE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2023-03-22
Active Ingredient
REPAGLINIDE
Application Number
207209
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2023-03-22
Regulatory Status
RX
Drug Name
REPAGLINIDE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2023-03-22
Active Ingredient
REPAGLINIDE
Application Number
207209
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2023-03-22
Regulatory Status
RX
Drug Name
REPAGLINIDE
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2023-03-22
Active Ingredient
REPAGLINIDE
Application Number
207209
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2023-03-22
Regulatory Status
RX
Drug Name
RIFAPENTINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2026-06-23
Active Ingredient
RIFAPENTINE
Application Number
217042
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2026-06-23
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-12-09
Active Ingredient
RISEDRONATE SODIUM
Application Number
203533
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2015-12-09
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2015-12-09
Active Ingredient
RISEDRONATE SODIUM
Application Number
203533
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2015-12-09
Regulatory Status
RX
Drug Name
RISEDRONATE SODIUM
Product Number
3
Dosage Form
-
Strength
35MG
Approval Date
2016-11-29
Active Ingredient
RISEDRONATE SODIUM
Application Number
203533
Product Number
3
Dosage Form
-
Strength
35MG
Approval Date
2016-11-29
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-05-14
Active Ingredient
RIVAROXABAN
Application Number
213114
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
213114
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
213114
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
213114
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
2014-08-22
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
203148
Product Number
1
Dosage Form
-
Strength
EQ 1.5MG BASE
Approval Date
2014-08-22
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2014-08-22
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
203148
Product Number
2
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2014-08-22
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2014-08-22
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
203148
Product Number
3
Dosage Form
-
Strength
EQ 4.5MG BASE
Approval Date
2014-08-22
Regulatory Status
RX
Drug Name
RIVASTIGMINE TARTRATE
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2014-08-22
Active Ingredient
RIVASTIGMINE TARTRATE
Application Number
203148
Product Number
4
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2014-08-22
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2014-09-19
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
203146
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2014-09-19
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2014-09-19
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
203146
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2014-09-19
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2014-02-11
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
203147
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2014-02-11
Regulatory Status
RX
Drug Name
RIZATRIPTAN BENZOATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2014-02-11
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
203147
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2014-02-11
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-11-06
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207296
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-11-06
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-11-06
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207296
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-11-06
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-11-06
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207296
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-11-06
Regulatory Status
Discontinued
Drug Name
ROSUVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-11-06
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
207296
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-11-06
Regulatory Status
Discontinued
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2024-10-16
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213728
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2024-10-16
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2024-10-16
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213728
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2024-10-16
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2024-10-16
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213728
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2024-10-16
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2023-04-19
Active Ingredient
SEVELAMER CARBONATE
Application Number
206100
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2023-04-19
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
1
Dosage Form
-
Strength
800MG/PACKET
Approval Date
2024-04-25
Active Ingredient
SEVELAMER CARBONATE
Application Number
207291
Product Number
1
Dosage Form
-
Strength
800MG/PACKET
Approval Date
2024-04-25
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
2
Dosage Form
-
Strength
2.4GM/PACKET
Approval Date
2024-04-25
Active Ingredient
SEVELAMER CARBONATE
Application Number
207291
Product Number
2
Dosage Form
-
Strength
2.4GM/PACKET
Approval Date
2024-04-25
Regulatory Status
RX
Drug Name
SEVELAMER HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2023-05-26
Active Ingredient
SEVELAMER HYDROCHLORIDE
Application Number
206883
Product Number
1
Dosage Form
-
Strength
400MG
Approval Date
2023-05-26
Regulatory Status
RX
Drug Name
SEVELAMER HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-05-26
Active Ingredient
SEVELAMER HYDROCHLORIDE
Application Number
206883
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-05-26
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2023-04-19
Active Ingredient
SILDENAFIL CITRATE
Application Number
202255
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2023-04-19
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-04-19
Active Ingredient
SILDENAFIL CITRATE
Application Number
202255
Product Number
2
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-04-19
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-04-19
Active Ingredient
SILDENAFIL CITRATE
Application Number
202255
Product Number
3
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-04-19
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-17
Active Ingredient
SILDENAFIL CITRATE
Application Number
203814
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2013-12-17
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-03
Active Ingredient
SILODOSIN
Application Number
211166
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
211166
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-03
Regulatory Status
RX
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
211073
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
211073
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SITAGLIPTIN PHOSPHATE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
SITAGLIPTIN PHOSPHATE
Application Number
211073
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
SOLIFENACIN SUCCINATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2024-02-20
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
204374
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2024-02-20
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2024-02-20
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
204374
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2024-02-20
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-10-07
Active Ingredient
TADALAFIL
Application Number
207244
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2019-10-07
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-10-07
Active Ingredient
TADALAFIL
Application Number
207244
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2019-10-07
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2019-10-07
Active Ingredient
TADALAFIL
Application Number
207244
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2019-10-07
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-10-07
Active Ingredient
TADALAFIL
Application Number
207244
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2019-10-07
Regulatory Status
RX
Drug Name
TADALAFIL
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-10-16
Active Ingredient
TADALAFIL
Application Number
207290
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2019-10-16
Regulatory Status
RX
Drug Name
TAMSULOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG
Approval Date
2017-01-20
Active Ingredient
TAMSULOSIN HYDROCHLORIDE
Application Number
204645
Product Number
1
Dosage Form
-
Strength
0.4MG
Approval Date
2017-01-20
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-01-15
Active Ingredient
TELMISARTAN
Application Number
203986
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2025-01-15
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2025-01-15
Active Ingredient
TELMISARTAN
Application Number
203986
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2025-01-15
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2025-01-15
Active Ingredient
TELMISARTAN
Application Number
203986
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2025-01-15
Regulatory Status
RX
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2015-11-02
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
204169
Product Number
1
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2015-11-02
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2015-11-02
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
204169
Product Number
2
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2015-11-02
Regulatory Status
Discontinued
Drug Name
TELMISARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2015-11-02
Active Ingredient
HYDROCHLOROTHIAZIDE; TELMISARTAN
Application Number
204169
Product Number
3
Dosage Form
-
Strength
25MG;80MG
Approval Date
2015-11-02
Regulatory Status
Discontinued
Drug Name
TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2018-01-26
Active Ingredient
TENOFOVIR DISOPROXIL FUMARATE
Application Number
203232
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2018-01-26
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2025-10-28
Active Ingredient
TICAGRELOR
Application Number
212258
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2025-10-28
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2025-10-28
Active Ingredient
TICAGRELOR
Application Number
212258
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2025-10-28
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2026-06-03
Active Ingredient
TOFACITINIB CITRATE
Application Number
219530
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2026-06-03
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-06-03
Active Ingredient
TOFACITINIB CITRATE
Application Number
219530
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-06-03
Regulatory Status
RX
Drug Name
TOLTERODINE TARTRATE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2015-08-31
Active Ingredient
TOLTERODINE TARTRATE
Application Number
203409
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2015-08-31
Regulatory Status
RX
Drug Name
TOLTERODINE TARTRATE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2015-08-31
Active Ingredient
TOLTERODINE TARTRATE
Application Number
203409
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2015-08-31
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2015-09-25
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
205702
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2015-09-25
Regulatory Status
Discontinued
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-01-31
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
209404
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-01-31
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-01-31
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
209404
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2025-01-31
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-01-31
Active Ingredient
TRAMADOL HYDROCHLORIDE
Application Number
209404
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-01-31
Regulatory Status
RX
Drug Name
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
2017-05-02
Active Ingredient
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Application Number
206885
Product Number
1
Dosage Form
-
Strength
325MG;37.5MG
Approval Date
2017-05-02
Regulatory Status
Discontinued
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2018-05-18
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
209535
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2018-05-18
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2018-05-18
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
209535
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2018-05-18
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
3
Dosage Form
-
Strength
0.5%
Approval Date
2018-05-18
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
209535
Product Number
3
Dosage Form
-
Strength
0.5%
Approval Date
2018-05-18
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2018-11-23
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
209828
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2018-11-23
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
209828
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
3
Dosage Form
-
Strength
0.5%
Approval Date
2018-11-23
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
209828
Product Number
3
Dosage Form
-
Strength
0.5%
Approval Date
2018-11-23
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2023-08-18
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
216625
Product Number
1
Dosage Form
-
Strength
0.05%
Approval Date
2023-08-18
Regulatory Status
RX
Drug Name
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
25MG;37.5MG
Approval Date
2025-01-28
Active Ingredient
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Application Number
214611
Product Number
1
Dosage Form
-
Strength
25MG;37.5MG
Approval Date
2025-01-28
Regulatory Status
Discontinued
Drug Name
TROSPIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-06-18
Active Ingredient
TROSPIUM CHLORIDE
Application Number
206472
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-06-18
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2016-09-16
Active Ingredient
VALSARTAN
Application Number
202696
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2016-09-16
Active Ingredient
VALSARTAN
Application Number
202696
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2016-09-16
Active Ingredient
VALSARTAN
Application Number
202696
Product Number
3
Dosage Form
-
Strength
160MG
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
VALSARTAN
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2016-09-16
Active Ingredient
VALSARTAN
Application Number
202696
Product Number
4
Dosage Form
-
Strength
320MG
Approval Date
2016-09-16
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2013-04-19
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
203145
Product Number
1
Dosage Form
-
Strength
12.5MG;80MG
Approval Date
2013-04-19
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2013-04-19
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
203145
Product Number
2
Dosage Form
-
Strength
12.5MG;160MG
Approval Date
2013-04-19
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2013-04-19
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
203145
Product Number
3
Dosage Form
-
Strength
12.5MG;320MG
Approval Date
2013-04-19
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
25MG;160MG
Approval Date
2013-04-19
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
203145
Product Number
4
Dosage Form
-
Strength
25MG;160MG
Approval Date
2013-04-19
Regulatory Status
RX
Drug Name
VALSARTAN AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2013-04-19
Active Ingredient
HYDROCHLOROTHIAZIDE; VALSARTAN
Application Number
203145
Product Number
5
Dosage Form
-
Strength
25MG;320MG
Approval Date
2013-04-19
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2019-10-22
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
204632
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2019-10-22
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2019-10-22
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
204632
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2019-10-22
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-10-22
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
204632
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-10-22
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-10-22
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
204632
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-10-22
Regulatory Status
RX
Drug Name
VARDENAFIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-03-10
Active Ingredient
VARDENAFIL HYDROCHLORIDE
Application Number
205988
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-03-10
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-12-09
Active Ingredient
VARENICLINE TARTRATE
Application Number
215048
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2024-12-09
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-12-09
Active Ingredient
VARENICLINE TARTRATE
Application Number
215048
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-12-09
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2017-10-05
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
204889
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2017-10-05
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-10-05
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
204889
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2017-10-05
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-10-05
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
204889
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2017-10-05
Regulatory Status
RX
Drug Name
VORTIOXETINE HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
-
Active Ingredient
VORTIOXETINE
Application Number
211165
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VORTIOXETINE HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
VORTIOXETINE
Application Number
211165
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VORTIOXETINE HYDROBROMIDE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
-
Active Ingredient
VORTIOXETINE
Application Number
211165
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
VORTIOXETINE HYDROBROMIDE
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
-
Active Ingredient
VORTIOXETINE
Application Number
211165
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-02-17
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204375
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-02-17
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-02-17
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204375
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-02-17
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2017-02-17
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204375
Product Number
3
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2017-02-17
Regulatory Status
RX
Drug Name
ZIPRASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2017-02-17
Active Ingredient
ZIPRASIDONE HYDROCHLORIDE
Application Number
204375
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2017-02-17
Regulatory Status
RX
Drug Name
ZOLMITRIPTAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2015-09-30
Active Ingredient
ZOLMITRIPTAN
Application Number
203772
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2015-09-30
Regulatory Status
Discontinued
Drug Name
ZOLMITRIPTAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-09-30
Active Ingredient
ZOLMITRIPTAN
Application Number
203772
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-09-30
Regulatory Status
Discontinued
Drug Name
ZOLMITRIPTAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2015-10-22
Active Ingredient
ZOLMITRIPTAN
Application Number
204336
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2015-10-22
Regulatory Status
Discontinued
Drug Name
ZOLMITRIPTAN
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-10-22
Active Ingredient
ZOLMITRIPTAN
Application Number
204336
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2015-10-22
Regulatory Status
Discontinued
Drug Name
ZONISAMIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-05-12
Active Ingredient
ZONISAMIDE
Application Number
219507
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-05-12
Regulatory Status
Discontinued
Drug Name
ZONISAMIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-05-12
Active Ingredient
ZONISAMIDE
Application Number
219507
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-05-12
Regulatory Status
Discontinued
Drug Name
ZONISAMIDE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2025-05-12
Active Ingredient
ZONISAMIDE
Application Number
219507
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2025-05-12
Regulatory Status
Discontinued
Drug Status Breakdown
427 total- Discontinued
- Unclassified
- 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
ABACAVIR SULFATE AND LAMIVUDINE
Application Number
212663
Product Number
1
Active Ingredient
ABACAVIR SULFATE; LAMIVUDINE
Dosage Form
-
Strength
EQ 600MG BASE;300MG
FDA Approved Drug Data
Approved drug product information
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