Mankind Pharma RX
FDA Approved Drugs
Mankind Pharma RX
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 117
- Latest Approval Date Jul 31, 2026
- Data Source FDA
- First Approval Date Apr 16, 2001
Company Overview
Social Profiles
Company Snapshot
Mankind Pharma RX
208, Okhla Industrial Estate, Phase III, New Delhi - 110020
India
www.mankindpharma.com/ contact@mankindpharma.com View on MapFDA Approved Drug Records ( 117 records )
Drug Name
ACETAZOLAMIDE
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2020-10-07
Active Ingredient
ACETAZOLAMIDE
Application Number
214282
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2020-10-07
Regulatory Status
RX
Drug Name
ACETAZOLAMIDE
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2020-10-07
Active Ingredient
ACETAZOLAMIDE
Application Number
214282
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2020-10-07
Regulatory Status
RX
Drug Name
ALOSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2020-09-09
Active Ingredient
ALOSETRON HYDROCHLORIDE
Application Number
213614
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2020-09-09
Regulatory Status
RX
Drug Name
ALOSETRON HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2020-09-09
Active Ingredient
ALOSETRON HYDROCHLORIDE
Application Number
213614
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2020-09-09
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-02-19
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
213999
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-02-19
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2021-02-19
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
213999
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2021-02-19
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2021-02-19
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
213999
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2021-02-19
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2021-02-19
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
213999
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2021-02-19
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2021-02-19
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
213999
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2021-02-19
Regulatory Status
RX
Drug Name
AMITRIPTYLINE HYDROCHLORIDE
Product Number
6
Dosage Form
-
Strength
150MG
Approval Date
2021-02-19
Active Ingredient
AMITRIPTYLINE HYDROCHLORIDE
Application Number
213999
Product Number
6
Dosage Form
-
Strength
150MG
Approval Date
2021-02-19
Regulatory Status
RX
Drug Name
APREMILAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-02-07
Active Ingredient
APREMILAST
Application Number
211734
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
APREMILAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-02-07
Active Ingredient
APREMILAST
Application Number
211734
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
APREMILAST
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-02-07
Active Ingredient
APREMILAST
Application Number
211734
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-02-07
Regulatory Status
RX
Drug Name
ARFORMOTEROL TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2022-11-15
Active Ingredient
ARFORMOTEROL TARTRATE
Application Number
216128
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2022-11-15
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-01-05
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217081
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-01-05
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-01-05
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217081
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-01-05
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-01-05
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217081
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2024-01-05
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-01-05
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
217081
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2024-01-05
Regulatory Status
RX
Drug Name
ATROPINE SULFATE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2024-01-08
Active Ingredient
ATROPINE SULFATE
Application Number
218148
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2024-01-08
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-01-25
Active Ingredient
BACLOFEN
Application Number
215885
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-01-25
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-01-25
Active Ingredient
BACLOFEN
Application Number
215885
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-01-25
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2022-01-25
Active Ingredient
BACLOFEN
Application Number
215885
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2022-01-25
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2025-03-17
Active Ingredient
BIMATOPROST
Application Number
218196
Product Number
1
Dosage Form
-
Strength
0.01%
Approval Date
2025-03-17
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-04-16
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
220398
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-04-16
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2025-04-03
Active Ingredient
BUMETANIDE
Application Number
219291
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2025-04-03
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2025-04-03
Active Ingredient
BUMETANIDE
Application Number
219291
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2025-04-03
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2025-04-03
Active Ingredient
BUMETANIDE
Application Number
219291
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2025-04-03
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-08-04
Active Ingredient
CHLORTHALIDONE
Application Number
215587
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-08-04
Regulatory Status
RX
Drug Name
CHLORTHALIDONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-08-04
Active Ingredient
CHLORTHALIDONE
Application Number
215587
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-08-04
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-04-08
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
211767
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-04-08
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2019-04-08
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
211767
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2019-04-08
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2019-04-08
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
211767
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2019-04-08
Regulatory Status
RX
Drug Name
CYANOCOBALAMIN
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-07-10
Active Ingredient
CYANOCOBALAMIN
Application Number
217839
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2024-07-10
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2025-08-12
Active Ingredient
DIVALPROEX SODIUM
Application Number
217358
Product Number
1
Dosage Form
-
Strength
EQ 125MG VALPROIC ACID
Approval Date
2025-08-12
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-02-09
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215710
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-02-09
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2022-02-09
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215710
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2022-02-09
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2022-02-09
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215710
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2022-02-09
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2022-02-09
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215710
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2022-02-09
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2022-02-09
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215710
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2022-02-09
Regulatory Status
RX
Drug Name
EPHEDRINE SULFATE
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2022-04-14
Active Ingredient
EPHEDRINE SULFATE
Application Number
216129
Product Number
1
Dosage Form
-
Strength
50MG/ML (50MG/ML)
Approval Date
2022-04-14
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-04-16
Active Ingredient
FAMOTIDINE
Application Number
75302
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2001-04-16
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-04-16
Active Ingredient
FAMOTIDINE
Application Number
75302
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2001-04-16
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2020-06-12
Active Ingredient
FENOFIBRATE
Application Number
213864
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2020-06-12
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2020-06-12
Active Ingredient
FENOFIBRATE
Application Number
213864
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2020-06-12
Regulatory Status
RX
Drug Name
FORMOTEROL FUMARATE
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2023-03-22
Active Ingredient
FORMOTEROL FUMARATE
Application Number
215883
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2023-03-22
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2022-12-16
Active Ingredient
FUROSEMIDE
Application Number
216860
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2022-12-16
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2024-04-11
Active Ingredient
HALOPERIDOL
Application Number
216918
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2024-04-11
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2024-04-11
Active Ingredient
HALOPERIDOL
Application Number
216918
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2024-04-11
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2024-04-11
Active Ingredient
HALOPERIDOL
Application Number
216918
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2024-04-11
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2024-04-11
Active Ingredient
HALOPERIDOL
Application Number
216918
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2024-04-11
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2024-04-11
Active Ingredient
HALOPERIDOL
Application Number
216918
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2024-04-11
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2024-04-11
Active Ingredient
HALOPERIDOL
Application Number
216918
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2024-04-11
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2023-05-23
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
216730
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE/ML
Approval Date
2023-05-23
Regulatory Status
RX
Drug Name
HALOPERIDOL DECANOATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2023-05-23
Active Ingredient
HALOPERIDOL DECANOATE
Application Number
216730
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE/ML
Approval Date
2023-05-23
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2023-06-16
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
217692
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2023-06-16
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2023-06-16
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
217692
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2023-06-16
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
1%
Approval Date
2023-11-29
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
217692
Product Number
3
Dosage Form
-
Strength
1%
Approval Date
2023-11-29
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2023-07-11
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
217693
Product Number
1
Dosage Form
-
Strength
1%
Approval Date
2023-07-11
Regulatory Status
RX
Drug Name
LIDOCAINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2023-07-11
Active Ingredient
LIDOCAINE HYDROCHLORIDE
Application Number
217693
Product Number
2
Dosage Form
-
Strength
2%
Approval Date
2023-07-11
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2023-11-01
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
217271
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2023-11-01
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-11-01
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
217271
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2023-11-01
Regulatory Status
RX
Drug Name
MIDODRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2023-11-01
Active Ingredient
MIDODRINE HYDROCHLORIDE
Application Number
217271
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2023-11-01
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2025-01-27
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
217988
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2025-01-27
Regulatory Status
RX
Drug Name
NALOXONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2024-02-29
Active Ingredient
NALOXONE HYDROCHLORIDE
Application Number
218404
Product Number
1
Dosage Form
-
Strength
0.4MG/ML
Approval Date
2024-02-29
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2022-11-14
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
216172
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2022-11-14
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2022-11-14
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
216172
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2022-11-14
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-11-14
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
216172
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-11-14
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2022-11-14
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
216172
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2022-11-14
Regulatory Status
RX
Drug Name
NICARDIPINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2009-11-17
Active Ingredient
NICARDIPINE HYDROCHLORIDE
Application Number
90671
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2009-11-17
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-03-21
Active Ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Application Number
217272
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-03-21
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-03-21
Active Ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Application Number
217272
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-03-21
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2023-03-21
Active Ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Application Number
217272
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2023-03-21
Regulatory Status
RX
Drug Name
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Product Number
1
Dosage Form
-
Strength
75MG;25MG
Approval Date
2023-07-11
Active Ingredient
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
Application Number
217357
Product Number
1
Dosage Form
-
Strength
75MG;25MG
Approval Date
2023-07-11
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2023-12-05
Active Ingredient
NITROGLYCERIN
Application Number
217970
Product Number
1
Dosage Form
-
Strength
0.3MG
Approval Date
2023-12-05
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2023-12-05
Active Ingredient
NITROGLYCERIN
Application Number
217970
Product Number
2
Dosage Form
-
Strength
0.4MG
Approval Date
2023-12-05
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2023-12-05
Active Ingredient
NITROGLYCERIN
Application Number
217970
Product Number
3
Dosage Form
-
Strength
0.6MG
Approval Date
2023-12-05
Regulatory Status
RX
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2022-11-23
Active Ingredient
OFLOXACIN
Application Number
215886
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2022-11-23
Regulatory Status
RX
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2022-07-14
Active Ingredient
OFLOXACIN
Application Number
216130
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2022-07-14
Regulatory Status
RX
Drug Name
OMEGA-3-ACID ETHYL ESTERS
Product Number
1
Dosage Form
-
Strength
1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date
2021-11-15
Active Ingredient
OMEGA-3-ACID ETHYL ESTERS
Application Number
215458
Product Number
1
Dosage Form
-
Strength
1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
Approval Date
2021-11-15
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2022-07-26
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
215880
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2022-07-26
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2023-01-11
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
216496
Product Number
1
Dosage Form
-
Strength
10%
Approval Date
2023-01-11
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5%
Approval Date
2022-09-29
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
216859
Product Number
1
Dosage Form
-
Strength
2.5%
Approval Date
2022-09-29
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2022-08-30
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
217069
Product Number
1
Dosage Form
-
Strength
10MG/ML (10MG/ML)
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2022-08-30
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
217069
Product Number
2
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
PHENYLEPHRINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2022-08-30
Active Ingredient
PHENYLEPHRINE HYDROCHLORIDE
Application Number
217069
Product Number
3
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2022-08-30
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2022-12-30
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
215697
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2022-12-30
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2022-12-30
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
215697
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2022-12-30
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2022-12-30
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
215697
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2022-12-30
Regulatory Status
RX
Drug Name
PROPARACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2025-05-21
Active Ingredient
PROPARACAINE HYDROCHLORIDE
Application Number
219136
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2025-05-21
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2026-01-27
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
216663
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2026-01-27
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
216663
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2026-01-27
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
216663
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
60MG
Approval Date
2026-01-27
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
216663
Product Number
4
Dosage Form
-
Strength
60MG
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
80MG
Approval Date
2026-01-27
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
216663
Product Number
5
Dosage Form
-
Strength
80MG
Approval Date
2026-01-27
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-02-12
Active Ingredient
RANOLAZINE
Application Number
212284
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-02-12
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2020-02-12
Active Ingredient
RANOLAZINE
Application Number
212284
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2020-02-12
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2026-07-01
Active Ingredient
RIVAROXABAN
Application Number
220874
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-07-01
Active Ingredient
RIVAROXABAN
Application Number
220874
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2026-07-01
Active Ingredient
RIVAROXABAN
Application Number
220874
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2026-07-01
Active Ingredient
RIVAROXABAN
Application Number
220874
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2026-07-01
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2025-05-29
Active Ingredient
ROCURONIUM BROMIDE
Application Number
219674
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2025-05-29
Regulatory Status
RX
Drug Name
ROCURONIUM BROMIDE
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2025-05-29
Active Ingredient
ROCURONIUM BROMIDE
Application Number
219674
Product Number
2
Dosage Form
-
Strength
100MG/10ML (10MG/ML)
Approval Date
2025-05-29
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
214230
Product Number
1
Dosage Form
-
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUGAMMADEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Active Ingredient
SUGAMMADEX SODIUM
Application Number
214230
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-10-15
Active Ingredient
TELMISARTAN
Application Number
218157
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-10-15
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2024-10-15
Active Ingredient
TELMISARTAN
Application Number
218157
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2024-10-15
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2024-10-15
Active Ingredient
TELMISARTAN
Application Number
218157
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2024-10-15
Regulatory Status
RX
Drug Name
THIAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2026-07-31
Active Ingredient
THIAMINE HYDROCHLORIDE
Application Number
220513
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2026-07-31
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2026-02-06
Active Ingredient
TICAGRELOR
Application Number
217679
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2026-02-06
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2026-02-06
Active Ingredient
TICAGRELOR
Application Number
217679
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2026-02-06
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2009-09-28
Active Ingredient
TIMOLOL MALEATE
Application Number
78771
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2009-09-28
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2009-09-28
Active Ingredient
TIMOLOL MALEATE
Application Number
78771
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2009-09-28
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2023-06-30
Active Ingredient
TOBRAMYCIN
Application Number
214478
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2023-06-30
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
300MG/4ML
Approval Date
2022-09-22
Active Ingredient
TOBRAMYCIN
Application Number
216725
Product Number
1
Dosage Form
-
Strength
300MG/4ML
Approval Date
2022-09-22
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2023-08-01
Active Ingredient
VARENICLINE TARTRATE
Application Number
214255
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2023-08-01
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-08-01
Active Ingredient
VARENICLINE TARTRATE
Application Number
214255
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2023-08-01
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2022-06-15
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
214653
Product Number
1
Dosage Form
-
Strength
2.5MG/ML
Approval Date
2022-06-15
Regulatory Status
RX
Drug Status Breakdown
117 total- RX
Official Source
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Drug Name
ACETAZOLAMIDE
Application Number
214282
Product Number
1
Active Ingredient
ACETAZOLAMIDE
Dosage Form
-
Strength
125MG
FDA Approved Drug Data
Approved drug product information
Regular Updates
Data maintained from official sources
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Searchable pharmaceutical data
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Organized FDA drug records
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