Micro Labs Limited RX
FDA Approved Drugs
Micro Labs Limited 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 191
- Latest Approval Date Jun 30, 2026
- Data Source FDA
- First Approval Date Feb 05, 1988
Company Overview
Social Profiles
Company Snapshot
Micro Labs Limited RX
27, RACE COURSE ROAD, BANGALORE-560 001
India
www.microlabsltd.com/ View on MapFDA Approved Drug Records ( 191 records )
Drug Name
ACETAZOLAMIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-10-01
Active Ingredient
ACETAZOLAMIDE
Application Number
207401
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-10-01
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2017-11-02
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207435
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;20MG
Approval Date
2017-11-02
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2017-11-02
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207435
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;40MG
Approval Date
2017-11-02
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2017-11-02
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207435
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE;20MG
Approval Date
2017-11-02
Regulatory Status
RX
Drug Name
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2017-11-02
Active Ingredient
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Application Number
207435
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;40MG
Approval Date
2017-11-02
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2022-06-24
Active Ingredient
AMOXICILLIN
Application Number
207471
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
AMOXICILLIN
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2022-06-24
Active Ingredient
AMOXICILLIN
Application Number
207471
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
3
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2016-12-30
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
204755
Product Number
3
Dosage Form
-
Strength
875MG;EQ 125MG BASE
Approval Date
2016-12-30
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2021-05-21
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
205187
Product Number
1
Dosage Form
-
Strength
200MG/5ML;EQ 28.5MG BASE/5ML
Approval Date
2021-05-21
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2021-05-21
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
205187
Product Number
2
Dosage Form
-
Strength
400MG/5ML;EQ 57MG BASE/5ML
Approval Date
2021-05-21
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
250MG;EQ 125MG BASE
Approval Date
2016-12-30
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
205707
Product Number
1
Dosage Form
-
Strength
250MG;EQ 125MG BASE
Approval Date
2016-12-30
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
2
Dosage Form
-
Strength
500MG;EQ 125MG BASE
Approval Date
2016-12-30
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
205707
Product Number
2
Dosage Form
-
Strength
500MG;EQ 125MG BASE
Approval Date
2016-12-30
Regulatory Status
RX
Drug Name
AMOXICILLIN AND CLAVULANATE POTASSIUM
Product Number
1
Dosage Form
-
Strength
600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date
2023-12-08
Active Ingredient
AMOXICILLIN; CLAVULANATE POTASSIUM
Application Number
217805
Product Number
1
Dosage Form
-
Strength
600MG/5ML;EQ 42.9MG BASE/5ML
Approval Date
2023-12-08
Regulatory Status
RX
Drug Name
ARFORMOTEROL TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2025-03-07
Active Ingredient
ARFORMOTEROL TARTRATE
Application Number
218555
Product Number
1
Dosage Form
-
Strength
EQ 0.015MG BASE/2ML
Approval Date
2025-03-07
Regulatory Status
RX
Drug Name
ASPIRIN AND DIPYRIDAMOLE
Product Number
1
Dosage Form
-
Strength
25MG;200MG
Approval Date
2021-08-11
Active Ingredient
ASPIRIN; DIPYRIDAMOLE
Application Number
209929
Product Number
1
Dosage Form
-
Strength
25MG;200MG
Approval Date
2021-08-11
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-11-07
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
205945
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-11-07
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-11-07
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
205945
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-11-07
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-11-07
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
205945
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-11-07
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2019-11-07
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
205945
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2019-11-07
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-11-08
Active Ingredient
BACLOFEN
Application Number
217687
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-11-08
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2023-11-08
Active Ingredient
BACLOFEN
Application Number
217687
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2023-11-08
Regulatory Status
RX
Drug Name
BACLOFEN
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2023-11-08
Active Ingredient
BACLOFEN
Application Number
217687
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2023-11-08
Regulatory Status
RX
Drug Name
BIMATOPROST
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2020-09-08
Active Ingredient
BIMATOPROST
Application Number
202505
Product Number
1
Dosage Form
-
Strength
0.03%
Approval Date
2020-09-08
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-03-09
Active Ingredient
BISOPROLOL FUMARATE
Application Number
218303
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-03-09
Regulatory Status
RX
Drug Name
BISOPROLOL FUMARATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-03-09
Active Ingredient
BISOPROLOL FUMARATE
Application Number
218303
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-03-09
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2023-11-22
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
217846
Product Number
1
Dosage Form
-
Strength
0.2%
Approval Date
2023-11-22
Regulatory Status
RX
Drug Name
BRIMONIDINE TARTRATE
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-05-07
Active Ingredient
BRIMONIDINE TARTRATE
Application Number
218558
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
2026-05-07
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2026-02-23
Active Ingredient
BRIVARACETAM
Application Number
214880
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2026-02-23
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2020-04-17
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
207403
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2020-04-17
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2020-04-17
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
207403
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2020-04-17
Regulatory Status
RX
Drug Name
CAFFEINE CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2017-12-14
Active Ingredient
CAFFEINE CITRATE
Application Number
207400
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2017-12-14
Regulatory Status
RX
Drug Name
CAFFEINE CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2019-12-16
Active Ingredient
CAFFEINE CITRATE
Application Number
213202
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Approval Date
2019-12-16
Regulatory Status
RX
Drug Name
CARBOPROST TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2024-04-03
Active Ingredient
CARBOPROST TROMETHAMINE
Application Number
218013
Product Number
1
Dosage Form
-
Strength
EQ 0.25MG BASE/ML
Approval Date
2024-04-03
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2018-04-30
Active Ingredient
CELECOXIB
Application Number
204776
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2018-04-30
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2018-04-30
Active Ingredient
CELECOXIB
Application Number
204776
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2018-04-30
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2018-04-30
Active Ingredient
CELECOXIB
Application Number
204776
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2018-04-30
Regulatory Status
RX
Drug Name
CELECOXIB
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2018-04-30
Active Ingredient
CELECOXIB
Application Number
204776
Product Number
4
Dosage Form
-
Strength
400MG
Approval Date
2018-04-30
Regulatory Status
RX
Drug Name
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2022-07-19
Active Ingredient
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Application Number
215835
Product Number
1
Dosage Form
-
Strength
5MG;2.5MG
Approval Date
2022-07-19
Regulatory Status
RX
Drug Name
CHOLESTYRAMINE
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/PACKET
Approval Date
2026-03-05
Active Ingredient
CHOLESTYRAMINE
Application Number
219318
Product Number
1
Dosage Form
-
Strength
EQ 4GM RESIN/PACKET
Approval Date
2026-03-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2018-11-05
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
207402
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2018-11-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-11-05
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
207402
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2018-11-05
Regulatory Status
RX
Drug Name
CLINDAMYCIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-11-05
Active Ingredient
CLINDAMYCIN HYDROCHLORIDE
Application Number
207402
Product Number
3
Dosage Form
-
Strength
EQ 300MG BASE
Approval Date
2018-11-05
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2019-01-30
Active Ingredient
CLOBAZAM
Application Number
211711
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2019-01-30
Active Ingredient
CLOBAZAM
Application Number
211711
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2019-01-30
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2020-06-22
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
213219
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2020-06-22
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2020-06-22
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
213219
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2020-06-22
Regulatory Status
RX
Drug Name
CLOMIPRAMINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2020-06-22
Active Ingredient
CLOMIPRAMINE HYDROCHLORIDE
Application Number
213219
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2020-06-22
Regulatory Status
RX
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2026-02-17
Active Ingredient
COLCHICINE
Application Number
212880
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2026-02-17
Regulatory Status
RX
Drug Name
CROMOLYN SODIUM
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2013-04-04
Active Ingredient
CROMOLYN SODIUM
Application Number
202745
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2013-04-04
Regulatory Status
RX
Drug Name
CROMOLYN SODIUM
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2022-04-29
Active Ingredient
CROMOLYN SODIUM
Application Number
213658
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2022-04-29
Regulatory Status
RX
Drug Name
DALFAMPRIDINE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2019-03-11
Active Ingredient
DALFAMPRIDINE
Application Number
210158
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2019-03-11
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211467
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
211467
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
211466
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
211466
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
211466
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
211466
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DEXAMETHASONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2024-03-27
Active Ingredient
DEXAMETHASONE SODIUM PHOSPHATE
Application Number
217797
Product Number
1
Dosage Form
-
Strength
EQ 10MG PHOSPHATE/ML
Approval Date
2024-03-27
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM AND MISOPROSTOL
Product Number
1
Dosage Form
-
Strength
50MG;0.2MG
Approval Date
2021-07-15
Active Ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Application Number
204355
Product Number
1
Dosage Form
-
Strength
50MG;0.2MG
Approval Date
2021-07-15
Regulatory Status
RX
Drug Name
DICLOFENAC SODIUM AND MISOPROSTOL
Product Number
2
Dosage Form
-
Strength
75MG;0.2MG
Approval Date
2021-07-15
Active Ingredient
DICLOFENAC SODIUM; MISOPROSTOL
Application Number
204355
Product Number
2
Dosage Form
-
Strength
75MG;0.2MG
Approval Date
2021-07-15
Regulatory Status
RX
Drug Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2018-08-22
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Application Number
205723
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2018-08-22
Regulatory Status
RX
Drug Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2025-08-22
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Application Number
219845
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2025-08-22
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2019-11-08
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE
Application Number
204778
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE
Approval Date
2019-11-08
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2020-05-28
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
204777
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2020-05-28
Regulatory Status
RX
Drug Name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2022-01-25
Active Ingredient
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Application Number
215936
Product Number
1
Dosage Form
-
Strength
EQ 2% BASE;EQ 0.5% BASE
Approval Date
2022-01-25
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2023-06-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
217688
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2023-06-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2023-06-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
217688
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2023-06-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-06-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
217688
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2023-06-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2023-06-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
217688
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2023-06-27
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-06-27
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
217688
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2023-06-27
Regulatory Status
RX
Drug Name
ERYTHRA-DERM
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1988-02-05
Active Ingredient
ERYTHROMYCIN
Application Number
62687
Product Number
1
Dosage Form
-
Strength
2%
Approval Date
1988-02-05
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2026-04-22
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
91655
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2026-04-22
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-04-22
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
91655
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-04-22
Regulatory Status
RX
Drug Name
ESCITALOPRAM OXALATE
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2026-04-22
Active Ingredient
ESCITALOPRAM OXALATE
Application Number
91655
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2026-04-22
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2023-09-14
Active Ingredient
FAMOTIDINE
Application Number
217842
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2023-09-14
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2020-06-16
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
213450
Product Number
1
Dosage Form
-
Strength
EQ 45MG FENOFIBRIC ACID
Approval Date
2020-06-16
Regulatory Status
RX
Drug Name
FENOFIBRIC ACID
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2020-06-16
Active Ingredient
CHOLINE FENOFIBRATE
Application Number
213450
Product Number
2
Dosage Form
-
Strength
EQ 135MG FENOFIBRIC ACID
Approval Date
2020-06-16
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-03-29
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
216232
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-03-29
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2022-03-29
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
216232
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2022-03-29
Regulatory Status
RX
Drug Name
FLUOXETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2022-03-29
Active Ingredient
FLUOXETINE HYDROCHLORIDE
Application Number
216232
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2022-03-29
Regulatory Status
RX
Drug Name
FLUVOXAMINE MALEATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2026-06-23
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
220768
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2026-06-23
Regulatory Status
RX
Drug Name
FLUVOXAMINE MALEATE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2026-06-23
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
220768
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2026-06-23
Regulatory Status
RX
Drug Name
FORMOTEROL FUMARATE
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2024-06-26
Active Ingredient
FORMOTEROL FUMARATE
Application Number
218304
Product Number
1
Dosage Form
-
Strength
0.02MG/2ML
Approval Date
2024-06-26
Regulatory Status
RX
Drug Name
FUROSEMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-01-08
Active Ingredient
FUROSEMIDE
Application Number
218188
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
91220
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
91220
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
91220
Product Number
3
Dosage Form
-
Strength
3MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
91220
Product Number
4
Dosage Form
-
Strength
4MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
5
Dosage Form
-
Strength
6MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
91220
Product Number
5
Dosage Form
-
Strength
6MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
GLIMEPIRIDE
Product Number
6
Dosage Form
-
Strength
8MG
Approval Date
2012-06-29
Active Ingredient
GLIMEPIRIDE
Application Number
91220
Product Number
6
Dosage Form
-
Strength
8MG
Approval Date
2012-06-29
Regulatory Status
RX
Drug Name
ISOPROTERENOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2021-02-16
Active Ingredient
ISOPROTERENOL HYDROCHLORIDE
Application Number
210845
Product Number
1
Dosage Form
-
Strength
0.2MG/ML
Approval Date
2021-02-16
Regulatory Status
RX
Drug Name
KETOROLAC TROMETHAMINE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2019-04-05
Active Ingredient
KETOROLAC TROMETHAMINE
Application Number
203410
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2019-04-05
Regulatory Status
RX
Drug Name
LATANOPROST
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2025-04-14
Active Ingredient
LATANOPROST
Application Number
219306
Product Number
1
Dosage Form
-
Strength
0.005%
Approval Date
2025-04-14
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2019-08-09
Active Ingredient
LEVETIRACETAM
Application Number
211954
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2019-08-09
Regulatory Status
RX
Drug Name
LEVOCETIRIZINE DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2013-09-17
Active Ingredient
LEVOCETIRIZINE DIHYDROCHLORIDE
Application Number
202046
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2013-09-17
Regulatory Status
RX
Drug Name
LEVOFLOXACIN
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2019-02-27
Active Ingredient
LEVOFLOXACIN
Application Number
205600
Product Number
1
Dosage Form
-
Strength
1.5%
Approval Date
2019-02-27
Regulatory Status
RX
Drug Name
LINCOMYCIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE/ML
Approval Date
2021-11-08
Active Ingredient
LINCOMYCIN HYDROCHLORIDE
Application Number
215082
Product Number
1
Dosage Form
-
Strength
EQ 300MG BASE/ML
Approval Date
2021-11-08
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2025-12-11
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
214696
Product Number
1
Dosage Form
-
Strength
100MG;25MG
Approval Date
2025-12-11
Regulatory Status
RX
Drug Name
LOPINAVIR AND RITONAVIR
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2025-12-11
Active Ingredient
LOPINAVIR; RITONAVIR
Application Number
214696
Product Number
2
Dosage Form
-
Strength
200MG;50MG
Approval Date
2025-12-11
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2012-09-24
Active Ingredient
LOSARTAN POTASSIUM
Application Number
91541
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2012-09-24
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2012-09-24
Active Ingredient
LOSARTAN POTASSIUM
Application Number
91541
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2012-09-24
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2012-09-24
Active Ingredient
LOSARTAN POTASSIUM
Application Number
91541
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2012-09-24
Regulatory Status
RX
Drug Name
MEFENAMIC ACID
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2010-11-19
Active Ingredient
MEFENAMIC ACID
Application Number
90562
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2010-11-19
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2023-01-10
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
212448
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2023-01-10
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2023-01-10
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
212448
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2023-01-10
Regulatory Status
RX
Drug Name
METHENAMINE HIPPURATE
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2019-08-01
Active Ingredient
METHENAMINE HIPPURATE
Application Number
212172
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2019-08-01
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2024-11-06
Active Ingredient
METOLAZONE
Application Number
217563
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2024-11-06
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2024-11-06
Active Ingredient
METOLAZONE
Application Number
217563
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2024-11-06
Regulatory Status
RX
Drug Name
METOLAZONE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2024-11-06
Active Ingredient
METOLAZONE
Application Number
217563
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2024-11-06
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2023-08-21
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
217504
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2023-08-21
Regulatory Status
RX
Drug Name
MIDAZOLAM HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2023-08-21
Active Ingredient
MIDAZOLAM HYDROCHLORIDE
Application Number
217504
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE/ML
Approval Date
2023-08-21
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2026-05-19
Active Ingredient
MIRTAZAPINE
Application Number
220104
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2026-05-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2026-05-19
Active Ingredient
MIRTAZAPINE
Application Number
220104
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2026-05-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2026-05-19
Active Ingredient
MIRTAZAPINE
Application Number
220104
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2026-05-19
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2026-05-19
Active Ingredient
MIRTAZAPINE
Application Number
220104
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2026-05-19
Regulatory Status
RX
Drug Name
MISOPROSTOL
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
2022-10-17
Active Ingredient
MISOPROSTOL
Application Number
216872
Product Number
1
Dosage Form
-
Strength
0.1MG
Approval Date
2022-10-17
Regulatory Status
RX
Drug Name
MISOPROSTOL
Product Number
2
Dosage Form
-
Strength
0.2MG
Approval Date
2022-10-17
Active Ingredient
MISOPROSTOL
Application Number
216872
Product Number
2
Dosage Form
-
Strength
0.2MG
Approval Date
2022-10-17
Regulatory Status
RX
Drug Name
NEVIRAPINE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Active Ingredient
NEVIRAPINE
Application Number
203080
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2012-05-22
Regulatory Status
RX
Drug Name
NICARDIPINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2023-07-07
Active Ingredient
NICARDIPINE HYDROCHLORIDE
Application Number
216420
Product Number
1
Dosage Form
-
Strength
25MG/10ML (2.5MG/ML)
Approval Date
2023-07-07
Regulatory Status
RX
Drug Name
OFLOXACIN
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2026-04-08
Active Ingredient
OFLOXACIN
Application Number
218557
Product Number
1
Dosage Form
-
Strength
0.3%
Approval Date
2026-04-08
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-09-17
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
206372
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-09-17
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2019-09-17
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
206372
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2019-09-17
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2019-09-17
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
206372
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2019-09-17
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2026-04-13
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
206371
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2026-04-13
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2026-04-13
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
206371
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2026-04-13
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2026-04-13
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
206371
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2026-04-13
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;20MG
Approval Date
2025-11-24
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207437
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;20MG
Approval Date
2025-11-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;40MG
Approval Date
2025-11-24
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207437
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE;12.5MG;40MG
Approval Date
2025-11-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;25MG;40MG
Approval Date
2025-11-24
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207437
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE;25MG;40MG
Approval Date
2025-11-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;40MG
Approval Date
2025-11-24
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207437
Product Number
4
Dosage Form
-
Strength
EQ 10MG BASE;12.5MG;40MG
Approval Date
2025-11-24
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDE
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;40MG
Approval Date
2025-11-24
Active Ingredient
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
207437
Product Number
5
Dosage Form
-
Strength
EQ 10MG BASE;25MG;40MG
Approval Date
2025-11-24
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-05-18
Active Ingredient
PIRFENIDONE
Application Number
212680
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-05-18
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-05-18
Active Ingredient
PIRFENIDONE
Application Number
212680
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-05-18
Regulatory Status
RX
Drug Name
PIROXICAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-12-29
Active Ingredient
PIROXICAM
Application Number
206152
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2017-12-29
Regulatory Status
RX
Drug Name
PIROXICAM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-12-29
Active Ingredient
PIROXICAM
Application Number
206152
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2017-12-29
Regulatory Status
RX
Drug Name
PROPARACAINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2025-10-20
Active Ingredient
PROPARACAINE HYDROCHLORIDE
Application Number
219294
Product Number
1
Dosage Form
-
Strength
0.5%
Approval Date
2025-10-20
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2026-06-24
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
217238
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2026-06-24
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2026-06-24
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
217238
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2026-06-24
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
2026-06-24
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
217238
Product Number
3
Dosage Form
-
Strength
120MG
Approval Date
2026-06-24
Regulatory Status
RX
Drug Name
PROPRANOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
160MG
Approval Date
2026-06-24
Active Ingredient
PROPRANOLOL HYDROCHLORIDE
Application Number
217238
Product Number
4
Dosage Form
-
Strength
160MG
Approval Date
2026-06-24
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-06-29
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
219180
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2026-06-29
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2026-06-29
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
219180
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2026-06-29
Regulatory Status
RX
Drug Name
RAMELTEON
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
2023-02-09
Active Ingredient
RAMELTEON
Application Number
215243
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
2023-02-09
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-02-27
Active Ingredient
RANOLAZINE
Application Number
211745
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-02-27
Regulatory Status
RX
Drug Name
RANOLAZINE
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2020-02-27
Active Ingredient
RANOLAZINE
Application Number
211745
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2020-02-27
Regulatory Status
RX
Drug Name
RASAGILINE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2019-03-29
Active Ingredient
RASAGILINE MESYLATE
Application Number
207004
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2019-03-29
Regulatory Status
RX
Drug Name
RASAGILINE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2019-03-29
Active Ingredient
RASAGILINE MESYLATE
Application Number
207004
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2019-03-29
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2026-06-30
Active Ingredient
RIVAROXABAN
Application Number
208334
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2026-06-30
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-06-30
Active Ingredient
RIVAROXABAN
Application Number
208334
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-06-30
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2026-06-30
Active Ingredient
RIVAROXABAN
Application Number
208334
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2026-06-30
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2026-06-30
Active Ingredient
RIVAROXABAN
Application Number
208334
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2026-06-30
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
1
Dosage Form
-
Strength
500MCG
Approval Date
2019-03-22
Active Ingredient
ROFLUMILAST
Application Number
208180
Product Number
1
Dosage Form
-
Strength
500MCG
Approval Date
2019-03-22
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
2
Dosage Form
-
Strength
250MCG
Approval Date
2023-04-18
Active Ingredient
ROFLUMILAST
Application Number
208180
Product Number
2
Dosage Form
-
Strength
250MCG
Approval Date
2023-04-18
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2023-05-15
Active Ingredient
RUFINAMIDE
Application Number
216688
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2023-05-15
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2023-05-15
Active Ingredient
RUFINAMIDE
Application Number
216688
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
2023-05-15
Regulatory Status
RX
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/PACKET
Approval Date
2026-01-08
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
219511
Product Number
1
Dosage Form
-
Strength
100MG/PACKET
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2026-01-08
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
219511
Product Number
2
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2026-01-08
Regulatory Status
RX
Drug Name
SEVELAMER CARBONATE
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2022-02-07
Active Ingredient
SEVELAMER CARBONATE
Application Number
215537
Product Number
1
Dosage Form
-
Strength
800MG
Approval Date
2022-02-07
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-09-16
Active Ingredient
SIMVASTATIN
Application Number
90383
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-09-16
Active Ingredient
SIMVASTATIN
Application Number
90383
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2011-09-16
Active Ingredient
SIMVASTATIN
Application Number
90383
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2011-09-16
Active Ingredient
SIMVASTATIN
Application Number
90383
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
SIMVASTATIN
Product Number
5
Dosage Form
-
Strength
80MG
Approval Date
2011-09-16
Active Ingredient
SIMVASTATIN
Application Number
90383
Product Number
5
Dosage Form
-
Strength
80MG
Approval Date
2011-09-16
Regulatory Status
RX
Drug Name
SODIUM NITROPRUSSIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2017-12-08
Active Ingredient
SODIUM NITROPRUSSIDE
Application Number
209352
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2017-12-08
Regulatory Status
RX
Drug Name
SUCCINYLCHOLINE CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-11-24
Active Ingredient
SUCCINYLCHOLINE CHLORIDE
Application Number
214879
Product Number
1
Dosage Form
-
Strength
20MG/ML
Approval Date
2020-11-24
Regulatory Status
RX
Drug Name
TAFLUPROST
Product Number
1
Dosage Form
-
Strength
0.0015%
Approval Date
2019-08-19
Active Ingredient
TAFLUPROST
Application Number
209051
Product Number
1
Dosage Form
-
Strength
0.0015%
Approval Date
2019-08-19
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2017-10-03
Active Ingredient
TELMISARTAN
Application Number
207016
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2017-10-03
Active Ingredient
TELMISARTAN
Application Number
207016
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
TELMISARTAN
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2017-10-03
Active Ingredient
TELMISARTAN
Application Number
207016
Product Number
3
Dosage Form
-
Strength
80MG
Approval Date
2017-10-03
Regulatory Status
RX
Drug Name
TENOFOVIR DISOPROXIL FUMARATE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2025-12-18
Active Ingredient
TENOFOVIR DISOPROXIL FUMARATE
Application Number
206157
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2025-12-18
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2026-04-27
Active Ingredient
TICAGRELOR
Application Number
208539
Product Number
1
Dosage Form
-
Strength
60MG
Approval Date
2026-04-27
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2026-04-27
Active Ingredient
TICAGRELOR
Application Number
208539
Product Number
2
Dosage Form
-
Strength
90MG
Approval Date
2026-04-27
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2022-09-07
Active Ingredient
TIMOLOL MALEATE
Application Number
216596
Product Number
1
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2022-09-07
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2023-05-26
Active Ingredient
TIMOLOL MALEATE
Application Number
217343
Product Number
1
Dosage Form
-
Strength
EQ 0.25% BASE
Approval Date
2023-05-26
Regulatory Status
RX
Drug Name
TIMOLOL MALEATE
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2023-05-26
Active Ingredient
TIMOLOL MALEATE
Application Number
217343
Product Number
2
Dosage Form
-
Strength
EQ 0.5% BASE
Approval Date
2023-05-26
Regulatory Status
RX
Drug Name
TOBRAMYCIN
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2023-07-27
Active Ingredient
TOBRAMYCIN
Application Number
217344
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2023-07-27
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-03-13
Active Ingredient
TOFACITINIB CITRATE
Application Number
209738
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2023-03-13
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
209738
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-06-03
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-05-01
Active Ingredient
TORSEMIDE
Application Number
217239
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-05-01
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-05-01
Active Ingredient
TORSEMIDE
Application Number
217239
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2026-05-01
Regulatory Status
RX
Drug Name
TORSEMIDE
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2026-05-01
Active Ingredient
TORSEMIDE
Application Number
217239
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2026-05-01
Regulatory Status
RX
Drug Name
TRANEXAMIC ACID
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2017-06-27
Active Ingredient
TRANEXAMIC ACID
Application Number
206713
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2017-06-27
Regulatory Status
RX
Drug Name
TRAVOPROST
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2021-03-19
Active Ingredient
TRAVOPROST
Application Number
203767
Product Number
1
Dosage Form
-
Strength
0.004%
Approval Date
2021-03-19
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2006-06-09
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
40671
Product Number
1
Dosage Form
-
Strength
0.025%
Approval Date
2006-06-09
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2006-06-09
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
40671
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2006-06-09
Regulatory Status
RX
Drug Name
TRIAMCINOLONE ACETONIDE
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2006-12-13
Active Ingredient
TRIAMCINOLONE ACETONIDE
Application Number
40672
Product Number
2
Dosage Form
-
Strength
0.1%
Approval Date
2006-12-13
Regulatory Status
RX
Drug Name
VALGANCICLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2026-03-19
Active Ingredient
VALGANCICLOVIR HYDROCHLORIDE
Application Number
218838
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2026-03-19
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-10-29
Active Ingredient
VARENICLINE TARTRATE
Application Number
218302
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-10-29
Regulatory Status
RX
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-10-29
Active Ingredient
VARENICLINE TARTRATE
Application Number
218302
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-10-29
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/2ML (2.5MG/ML)
Approval Date
2018-12-28
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
211370
Product Number
1
Dosage Form
-
Strength
5MG/2ML (2.5MG/ML)
Approval Date
2018-12-28
Regulatory Status
RX
Drug Name
VERAPAMIL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG/4ML (2.5MG/ML)
Approval Date
2018-12-28
Active Ingredient
VERAPAMIL HYDROCHLORIDE
Application Number
211370
Product Number
2
Dosage Form
-
Strength
10MG/4ML (2.5MG/ML)
Approval Date
2018-12-28
Regulatory Status
RX
Drug Status Breakdown
191 total- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
Visit FDA Orange BookFDA Approved Drug Record Details Preview
Explore important FDA approved drug information available in the records above.
Drug Name
ACETAZOLAMIDE
Application Number
207401
Product Number
1
Active Ingredient
ACETAZOLAMIDE
Dosage Form
-
Strength
500MG
FDA Approved Drug Data
Approved drug product information
Regular Updates
Data maintained from official sources
Structured Database
Searchable pharmaceutical data
Reliable Data
Organized FDA drug records
Create a New Buying Request
Fields marked with * are mandatory.