MSN Laboratories RX
FDA Approved Drugs
MSN Laboratories 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 252
- Latest Approval Date Jul 28, 2026
- Data Source FDA
- First Approval Date Sep 22, 2017
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MSN Laboratories RX
MSN House Plot No: C-24 Industrial Estate, Sanathnagar Hyderabad - 18 Telangana
India
www.msnlabs.com/ api@msnlabs.com View on MapFDA Approved Drug Records ( 252 records )
Drug Name
ABIRATERONE ACETATE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2019-07-10
Active Ingredient
ABIRATERONE ACETATE
Application Number
210686
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2019-07-10
Regulatory Status
RX
Drug Name
ABIRATERONE ACETATE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2024-04-24
Active Ingredient
ABIRATERONE ACETATE
Application Number
210686
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2024-04-24
Regulatory Status
RX
Drug Name
ACYCLOVIR
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2023-03-09
Active Ingredient
ACYCLOVIR
Application Number
217393
Product Number
1
Dosage Form
-
Strength
200MG/5ML
Approval Date
2023-03-09
Regulatory Status
RX
Drug Name
ALBENDAZOLE
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2021-01-21
Active Ingredient
ALBENDAZOLE
Application Number
213435
Product Number
1
Dosage Form
-
Strength
200MG
Approval Date
2021-01-21
Regulatory Status
RX
Drug Name
AMINOCAPROIC ACID
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-11-06
Active Ingredient
AMINOCAPROIC ACID
Application Number
212938
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2020-11-06
Regulatory Status
RX
Drug Name
AMINOCAPROIC ACID
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2023-09-13
Active Ingredient
AMINOCAPROIC ACID
Application Number
212938
Product Number
2
Dosage Form
-
Strength
1GM
Approval Date
2023-09-13
Regulatory Status
RX
Drug Name
AMINOCAPROIC ACID
Product Number
1
Dosage Form
-
Strength
0.25GM/ML
Approval Date
2024-09-26
Active Ingredient
AMINOCAPROIC ACID
Application Number
215100
Product Number
1
Dosage Form
-
Strength
0.25GM/ML
Approval Date
2024-09-26
Regulatory Status
RX
Drug Name
APREMILAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-12-16
Active Ingredient
APREMILAST
Application Number
211887
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-12-16
Regulatory Status
RX
Drug Name
APREMILAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-12-16
Active Ingredient
APREMILAST
Application Number
211887
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-12-16
Regulatory Status
RX
Drug Name
APREMILAST
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-12-16
Active Ingredient
APREMILAST
Application Number
211887
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-12-16
Regulatory Status
RX
Drug Name
ARSENIC TRIOXIDE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-04-20
Active Ingredient
ARSENIC TRIOXIDE
Application Number
217413
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-04-20
Regulatory Status
RX
Drug Name
ARSENIC TRIOXIDE
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
2023-04-20
Active Ingredient
ARSENIC TRIOXIDE
Application Number
217413
Product Number
2
Dosage Form
-
Strength
2MG/ML
Approval Date
2023-04-20
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-02-08
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
211933
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2019-02-08
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-02-08
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
211933
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2019-02-08
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-02-08
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
211933
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2019-02-08
Regulatory Status
RX
Drug Name
ATORVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2019-02-08
Active Ingredient
ATORVASTATIN CALCIUM
Application Number
211933
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE
Approval Date
2019-02-08
Regulatory Status
RX
Drug Name
AZACITIDINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2024-05-16
Active Ingredient
AZACITIDINE
Application Number
212580
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2024-05-16
Regulatory Status
RX
Drug Name
BORTEZOMIB
Product Number
1
Dosage Form
-
Strength
3.5MG/VIAL
Approval Date
2022-07-26
Active Ingredient
BORTEZOMIB
Application Number
209622
Product Number
1
Dosage Form
-
Strength
3.5MG/VIAL
Approval Date
2022-07-26
Regulatory Status
RX
Drug Name
BOSUTINIB MONOHYDRATE
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2026-06-12
Active Ingredient
BOSUTINIB MONOHYDRATE
Application Number
209624
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2026-06-12
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-11-13
Active Ingredient
BRIVARACETAM
Application Number
214921
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-11-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2025-11-13
Active Ingredient
BRIVARACETAM
Application Number
214921
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2025-11-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2025-11-13
Active Ingredient
BRIVARACETAM
Application Number
214921
Product Number
3
Dosage Form
-
Strength
50MG
Approval Date
2025-11-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2025-11-13
Active Ingredient
BRIVARACETAM
Application Number
214921
Product Number
4
Dosage Form
-
Strength
75MG
Approval Date
2025-11-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-11-13
Active Ingredient
BRIVARACETAM
Application Number
214921
Product Number
5
Dosage Form
-
Strength
100MG
Approval Date
2025-11-13
Regulatory Status
RX
Drug Name
BRIVARACETAM
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-02-19
Active Ingredient
BRIVARACETAM
Application Number
214922
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2026-02-19
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
214924
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2026-02-23
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2026-02-05
Active Ingredient
BUMETANIDE
Application Number
215362
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2026-02-05
Active Ingredient
BUMETANIDE
Application Number
215362
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2026-02-05
Active Ingredient
BUMETANIDE
Application Number
215362
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2026-02-05
Regulatory Status
RX
Drug Name
BUMETANIDE
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2022-08-04
Active Ingredient
BUMETANIDE
Application Number
215364
Product Number
1
Dosage Form
-
Strength
0.25MG/ML
Approval Date
2022-08-04
Regulatory Status
RX
Drug Name
CANGRELOR
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2026-06-04
Active Ingredient
CANGRELOR
Application Number
213703
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2026-06-04
Regulatory Status
RX
Drug Name
CAPECITABINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2018-07-02
Active Ingredient
CAPECITABINE
Application Number
209365
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2018-07-02
Regulatory Status
RX
Drug Name
CAPECITABINE
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2018-07-02
Active Ingredient
CAPECITABINE
Application Number
209365
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2018-07-02
Regulatory Status
RX
Drug Name
CARFILZOMIB
Product Number
1
Dosage Form
-
Strength
60MG/VIAL
Approval Date
2026-07-20
Active Ingredient
CARFILZOMIB
Application Number
209526
Product Number
1
Dosage Form
-
Strength
60MG/VIAL
Approval Date
2026-07-20
Regulatory Status
RX
Drug Name
CARMUSTINE
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-05-11
Active Ingredient
CARMUSTINE
Application Number
214814
Product Number
1
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2023-05-11
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-01-27
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
214827
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2022-01-27
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-01-27
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
214827
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2022-01-27
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2022-01-27
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
214827
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2022-01-27
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2022-01-27
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
214827
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2022-01-27
Regulatory Status
RX
Drug Name
CHLORPROMAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2026-01-26
Active Ingredient
CHLORPROMAZINE HYDROCHLORIDE
Application Number
216092
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2026-01-26
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-05-11
Active Ingredient
CLOBAZAM
Application Number
213404
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2021-05-11
Regulatory Status
RX
Drug Name
CLOBAZAM
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-05-11
Active Ingredient
CLOBAZAM
Application Number
213404
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2021-05-11
Regulatory Status
RX
Drug Name
CLOFARABINE
Product Number
1
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2017-12-06
Active Ingredient
CLOFARABINE
Application Number
209775
Product Number
1
Dosage Form
-
Strength
20MG/20ML (1MG/ML)
Approval Date
2017-12-06
Regulatory Status
RX
Drug Name
CLOPIDOGREL BISULFATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-09-20
Active Ingredient
CLOPIDOGREL BISULFATE
Application Number
215388
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-09-20
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-05-22
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
213879
Product Number
1
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2024-05-22
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-05-22
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
213879
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2024-05-22
Regulatory Status
RX
Drug Name
DABIGATRAN ETEXILATE MESYLATE
Product Number
3
Dosage Form
-
Strength
EQ 110MG BASE
Approval Date
2024-08-12
Active Ingredient
DABIGATRAN ETEXILATE MESYLATE
Application Number
213879
Product Number
3
Dosage Form
-
Strength
EQ 110MG BASE
Approval Date
2024-08-12
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN
Application Number
211478
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
211478
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
211479
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
211479
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
211479
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
211479
Product Number
4
Dosage Form
-
Strength
10MG;1GM
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG;EQ 5MG BASE
Approval Date
2026-04-06
Active Ingredient
DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE
Application Number
211533
Product Number
1
Dosage Form
-
Strength
10MG;EQ 5MG BASE
Approval Date
2026-04-06
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2023-11-28
Active Ingredient
DARUNAVIR
Application Number
215389
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2023-11-28
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-11-28
Active Ingredient
DARUNAVIR
Application Number
215389
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2023-11-28
Regulatory Status
RX
Drug Name
DECITABINE
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2019-08-28
Active Ingredient
DECITABINE
Application Number
212265
Product Number
1
Dosage Form
-
Strength
50MG/VIAL
Approval Date
2019-08-28
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
209878
Product Number
1
Dosage Form
-
Strength
125MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
209878
Product Number
2
Dosage Form
-
Strength
250MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
209878
Product Number
3
Dosage Form
-
Strength
500MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
210945
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2019-11-20
Active Ingredient
DEFERASIROX
Application Number
210945
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2019-11-20
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
2020-06-16
Active Ingredient
DEFERASIROX
Application Number
210945
Product Number
3
Dosage Form
-
Strength
180MG
Approval Date
2020-06-16
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
180MG
Approval Date
2021-03-17
Active Ingredient
DEFERASIROX
Application Number
214650
Product Number
1
Dosage Form
-
Strength
180MG
Approval Date
2021-03-17
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2021-03-17
Active Ingredient
DEFERASIROX
Application Number
214650
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2021-03-17
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2022-04-20
Active Ingredient
DEFERASIROX
Application Number
214650
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2022-04-20
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2025-03-26
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
216748
Product Number
1
Dosage Form
-
Strength
EQ 250MG BASE/VIAL
Approval Date
2025-03-26
Regulatory Status
RX
Drug Name
DEXRAZOXANE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2025-03-26
Active Ingredient
DEXRAZOXANE HYDROCHLORIDE
Application Number
216748
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/VIAL
Approval Date
2025-03-26
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2020-09-24
Active Ingredient
DIMETHYL FUMARATE
Application Number
210460
Product Number
1
Dosage Form
-
Strength
120MG
Approval Date
2020-09-24
Regulatory Status
RX
Drug Name
DIMETHYL FUMARATE
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2020-09-24
Active Ingredient
DIMETHYL FUMARATE
Application Number
210460
Product Number
2
Dosage Form
-
Strength
240MG
Approval Date
2020-09-24
Regulatory Status
RX
Drug Name
DOFETILIDE
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2020-01-29
Active Ingredient
DOFETILIDE
Application Number
213220
Product Number
1
Dosage Form
-
Strength
0.125MG
Approval Date
2020-01-29
Regulatory Status
RX
Drug Name
DOFETILIDE
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2020-01-29
Active Ingredient
DOFETILIDE
Application Number
213220
Product Number
2
Dosage Form
-
Strength
0.25MG
Approval Date
2020-01-29
Regulatory Status
RX
Drug Name
DOFETILIDE
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2020-01-29
Active Ingredient
DOFETILIDE
Application Number
213220
Product Number
3
Dosage Form
-
Strength
0.5MG
Approval Date
2020-01-29
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2023-04-03
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
214823
Product Number
1
Dosage Form
-
Strength
EQ 3MG BASE
Approval Date
2023-04-03
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2023-04-03
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
214823
Product Number
2
Dosage Form
-
Strength
EQ 6MG BASE
Approval Date
2023-04-03
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-06-24
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215113
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2022-06-24
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215113
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2022-06-24
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215113
Product Number
3
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2022-06-24
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215113
Product Number
4
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
DOXEPIN HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2022-06-24
Active Ingredient
DOXEPIN HYDROCHLORIDE
Application Number
215113
Product Number
5
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2022-06-24
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG ACID
Approval Date
2026-01-14
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220250
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG ACID
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
2
Dosage Form
-
Strength
EQ 25MG ACID
Approval Date
2026-01-14
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220250
Product Number
2
Dosage Form
-
Strength
EQ 25MG ACID
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
3
Dosage Form
-
Strength
EQ 50MG ACID
Approval Date
2026-01-14
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220250
Product Number
3
Dosage Form
-
Strength
EQ 50MG ACID
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
4
Dosage Form
-
Strength
EQ 75MG ACID
Approval Date
2026-01-14
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
220250
Product Number
4
Dosage Form
-
Strength
EQ 75MG ACID
Approval Date
2026-01-14
Regulatory Status
RX
Drug Name
ERLOTINIB HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-05-10
Active Ingredient
ERLOTINIB HYDROCHLORIDE
Application Number
214366
Product Number
1
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2021-05-10
Regulatory Status
RX
Drug Name
ERLOTINIB HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2021-05-10
Active Ingredient
ERLOTINIB HYDROCHLORIDE
Application Number
214366
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2021-05-10
Regulatory Status
RX
Drug Name
ERLOTINIB HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2021-05-10
Active Ingredient
ERLOTINIB HYDROCHLORIDE
Application Number
214366
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2021-05-10
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-08-06
Active Ingredient
FAMOTIDINE
Application Number
217400
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-08-06
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2024-08-06
Active Ingredient
FAMOTIDINE
Application Number
217400
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2024-08-06
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2025-07-24
Active Ingredient
FAMOTIDINE
Application Number
219863
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2025-07-24
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2019-12-30
Active Ingredient
FEBUXOSTAT
Application Number
210461
Product Number
1
Dosage Form
-
Strength
40MG
Approval Date
2019-12-30
Regulatory Status
RX
Drug Name
FEBUXOSTAT
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2019-12-30
Active Ingredient
FEBUXOSTAT
Application Number
210461
Product Number
2
Dosage Form
-
Strength
80MG
Approval Date
2019-12-30
Regulatory Status
RX
Drug Name
FLUPHENAZINE DECANOATE
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2023-11-02
Active Ingredient
FLUPHENAZINE DECANOATE
Application Number
215365
Product Number
1
Dosage Form
-
Strength
25MG/ML
Approval Date
2023-11-02
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2023-09-11
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217189
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2023-09-11
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2023-09-11
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217189
Product Number
2
Dosage Form
-
Strength
2.5MG
Approval Date
2023-09-11
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2023-09-11
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217189
Product Number
3
Dosage Form
-
Strength
5MG
Approval Date
2023-09-11
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2023-09-11
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
217189
Product Number
4
Dosage Form
-
Strength
10MG
Approval Date
2023-09-11
Regulatory Status
RX
Drug Name
FOSAPREPITANT DIMEGLUMINE
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2019-09-05
Active Ingredient
FOSAPREPITANT DIMEGLUMINE
Application Number
209965
Product Number
1
Dosage Form
-
Strength
EQ 150MG BASE/VIAL
Approval Date
2019-09-05
Regulatory Status
RX
Drug Name
GLYCEROL PHENYLBUTYRATE
Product Number
1
Dosage Form
-
Strength
1.1GM/ML
Approval Date
2026-04-15
Active Ingredient
GLYCEROL PHENYLBUTYRATE
Application Number
219540
Product Number
1
Dosage Form
-
Strength
1.1GM/ML
Approval Date
2026-04-15
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
2025-04-08
Active Ingredient
GLYCOPYRROLATE
Application Number
216084
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
2025-04-08
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2022-11-18
Active Ingredient
HALOPERIDOL
Application Number
216004
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2022-11-18
Active Ingredient
HALOPERIDOL
Application Number
216004
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2022-11-18
Active Ingredient
HALOPERIDOL
Application Number
216004
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2022-11-18
Active Ingredient
HALOPERIDOL
Application Number
216004
Product Number
4
Dosage Form
-
Strength
5MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2022-11-18
Active Ingredient
HALOPERIDOL
Application Number
216004
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2022-11-18
Active Ingredient
HALOPERIDOL
Application Number
216004
Product Number
6
Dosage Form
-
Strength
20MG
Approval Date
2022-11-18
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2025-11-04
Active Ingredient
IRBESARTAN
Application Number
219539
Product Number
1
Dosage Form
-
Strength
75MG
Approval Date
2025-11-04
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-11-04
Active Ingredient
IRBESARTAN
Application Number
219539
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-11-04
Regulatory Status
RX
Drug Name
IRBESARTAN
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-11-04
Active Ingredient
IRBESARTAN
Application Number
219539
Product Number
3
Dosage Form
-
Strength
300MG
Approval Date
2025-11-04
Regulatory Status
RX
Drug Name
ISOSULFAN BLUE
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2022-09-16
Active Ingredient
ISOSULFAN BLUE
Application Number
216090
Product Number
1
Dosage Form
-
Strength
50MG/5ML (10MG/ML)
Approval Date
2022-09-16
Regulatory Status
RX
Drug Name
IVABRADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2025-04-28
Active Ingredient
IVABRADINE HYDROCHLORIDE
Application Number
213483
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2025-04-28
Regulatory Status
RX
Drug Name
IVABRADINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2025-04-28
Active Ingredient
IVABRADINE HYDROCHLORIDE
Application Number
213483
Product Number
2
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2025-04-28
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204921
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204921
Product Number
2
Dosage Form
-
Strength
100MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204921
Product Number
3
Dosage Form
-
Strength
150MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2022-03-17
Active Ingredient
LACOSAMIDE
Application Number
204921
Product Number
4
Dosage Form
-
Strength
200MG
Approval Date
2022-03-17
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2023-12-22
Active Ingredient
LACOSAMIDE
Application Number
215379
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2023-12-22
Regulatory Status
RX
Drug Name
LACOSAMIDE
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2023-02-09
Active Ingredient
LACOSAMIDE
Application Number
215979
Product Number
1
Dosage Form
-
Strength
200MG/20ML (10MG/ML)
Approval Date
2023-02-09
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2022-07-15
Active Ingredient
LEVETIRACETAM
Application Number
214757
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2022-07-15
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2022-10-07
Active Ingredient
LEVETIRACETAM
Application Number
214815
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2022-10-07
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2022-10-07
Active Ingredient
LEVETIRACETAM
Application Number
214815
Product Number
2
Dosage Form
-
Strength
500MG
Approval Date
2022-10-07
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2022-10-07
Active Ingredient
LEVETIRACETAM
Application Number
214815
Product Number
3
Dosage Form
-
Strength
750MG
Approval Date
2022-10-07
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2022-10-07
Active Ingredient
LEVETIRACETAM
Application Number
214815
Product Number
4
Dosage Form
-
Strength
1GM
Approval Date
2022-10-07
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2022-11-15
Active Ingredient
LEVETIRACETAM
Application Number
215980
Product Number
1
Dosage Form
-
Strength
500MG/5ML (100MG/ML)
Approval Date
2022-11-15
Regulatory Status
RX
Drug Name
LINAGLIPTIN
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN
Application Number
208457
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Application Number
208459
Product Number
1
Dosage Form
-
Strength
2.5MG;500MG
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
2.5MG;850MG
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Application Number
208459
Product Number
2
Dosage Form
-
Strength
2.5MG;850MG
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
2.5MG;1GM
Approval Date
2025-11-03
Active Ingredient
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Application Number
208459
Product Number
3
Dosage Form
-
Strength
2.5MG;1GM
Approval Date
2025-11-03
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-02-02
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
218306
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-02-02
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
218306
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-02-02
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
218306
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2024-02-02
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
218306
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2024-02-02
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
218306
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2024-02-02
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
218306
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2024-02-02
Regulatory Status
RX
Drug Name
LOFEXIDINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 0.18MG BASE
Approval Date
2025-02-24
Active Ingredient
LOFEXIDINE HYDROCHLORIDE
Application Number
218699
Product Number
1
Dosage Form
-
Strength
EQ 0.18MG BASE
Approval Date
2025-02-24
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-08-14
Active Ingredient
LOSARTAN POTASSIUM
Application Number
217396
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-08-14
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-08-14
Active Ingredient
LOSARTAN POTASSIUM
Application Number
217396
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-08-14
Regulatory Status
RX
Drug Name
LOSARTAN POTASSIUM
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2023-08-14
Active Ingredient
LOSARTAN POTASSIUM
Application Number
217396
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2023-08-14
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2022-09-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208037
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2022-09-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2022-09-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208037
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2022-09-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2022-09-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208037
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2022-09-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2022-09-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208037
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2022-09-09
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2022-09-09
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
208037
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2022-09-09
Regulatory Status
RX
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-08-20
Active Ingredient
MACITENTAN
Application Number
211136
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2025-08-20
Regulatory Status
RX
Drug Name
MIRABEGRON
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-11-04
Active Ingredient
MIRABEGRON
Application Number
218543
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-11-04
Regulatory Status
RX
Drug Name
MIRABEGRON
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-11-04
Active Ingredient
MIRABEGRON
Application Number
218543
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-11-04
Regulatory Status
RX
Drug Name
MOXIFLOXACIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-09-22
Active Ingredient
MOXIFLOXACIN HYDROCHLORIDE
Application Number
208682
Product Number
1
Dosage Form
-
Strength
EQ 400MG BASE
Approval Date
2017-09-22
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2024-10-01
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
217397
Product Number
1
Dosage Form
-
Strength
EQ 2.5MG BASE
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-10-01
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
217397
Product Number
2
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-10-01
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
217397
Product Number
3
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
NEBIVOLOL HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-10-01
Active Ingredient
NEBIVOLOL HYDROCHLORIDE
Application Number
217397
Product Number
4
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2024-10-01
Regulatory Status
RX
Drug Name
NELARABINE
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2024-09-13
Active Ingredient
NELARABINE
Application Number
216948
Product Number
1
Dosage Form
-
Strength
250MG/50ML (5MG/ML)
Approval Date
2024-09-13
Regulatory Status
RX
Drug Name
NILOTINIB HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2025-11-19
Active Ingredient
NILOTINIB HYDROCHLORIDE
Application Number
218544
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2025-11-19
Regulatory Status
RX
Drug Name
NILOTINIB HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-11-19
Active Ingredient
NILOTINIB HYDROCHLORIDE
Application Number
218544
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2025-11-19
Regulatory Status
RX
Drug Name
NILOTINIB HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2025-11-19
Active Ingredient
NILOTINIB HYDROCHLORIDE
Application Number
218544
Product Number
3
Dosage Form
-
Strength
EQ 200MG BASE
Approval Date
2025-11-19
Regulatory Status
RX
Drug Name
NOREPINEPHRINE BITARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2025-12-11
Active Ingredient
NOREPINEPHRINE BITARTRATE
Application Number
218595
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2025-12-11
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-01-18
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
217399
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2023-01-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-01-18
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
217399
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-01-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2023-01-18
Active Ingredient
OLMESARTAN MEDOXOMIL
Application Number
217399
Product Number
3
Dosage Form
-
Strength
40MG
Approval Date
2023-01-18
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2025-09-26
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
217398
Product Number
1
Dosage Form
-
Strength
12.5MG;20MG
Approval Date
2025-09-26
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2025-09-26
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
217398
Product Number
2
Dosage Form
-
Strength
12.5MG;40MG
Approval Date
2025-09-26
Regulatory Status
RX
Drug Name
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2025-09-26
Active Ingredient
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Application Number
217398
Product Number
3
Dosage Form
-
Strength
25MG;40MG
Approval Date
2025-09-26
Regulatory Status
RX
Drug Name
OLUMIANT
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2025-08-08
Active Ingredient
BARICITINIB
Application Number
217585
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
OLUMIANT
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2025-08-08
Active Ingredient
BARICITINIB
Application Number
217585
Product Number
2
Dosage Form
-
Strength
2MG
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
OLUMIANT
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2025-08-08
Active Ingredient
BARICITINIB
Application Number
217585
Product Number
3
Dosage Form
-
Strength
4MG
Approval Date
2025-08-08
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2020-05-20
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
212544
Product Number
1
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2020-05-20
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2020-05-20
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
212544
Product Number
2
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2020-05-20
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-05-20
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
212544
Product Number
3
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2020-05-20
Regulatory Status
RX
Drug Name
OSELTAMIVIR PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2022-05-02
Active Ingredient
OSELTAMIVIR PHOSPHATE
Application Number
215313
Product Number
1
Dosage Form
-
Strength
EQ 6MG BASE/ML
Approval Date
2022-05-02
Regulatory Status
RX
Drug Name
OXCARBAZEPINE
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2026-05-29
Active Ingredient
OXCARBAZEPINE
Application Number
209020
Product Number
1
Dosage Form
-
Strength
300MG/5ML
Approval Date
2026-05-29
Regulatory Status
RX
Drug Name
PACLITAXEL
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2020-08-24
Active Ingredient
PACLITAXEL
Application Number
213434
Product Number
1
Dosage Form
-
Strength
6MG/ML
Approval Date
2020-08-24
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
2025-07-11
Active Ingredient
PERAMPANEL
Application Number
218152
Product Number
1
Dosage Form
-
Strength
0.5MG/ML
Approval Date
2025-07-11
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2025-11-25
Active Ingredient
PERAMPANEL
Application Number
218178
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2025-11-25
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2025-11-25
Active Ingredient
PERAMPANEL
Application Number
218178
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2025-11-25
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
3
Dosage Form
-
Strength
6MG
Approval Date
2025-11-25
Active Ingredient
PERAMPANEL
Application Number
218178
Product Number
3
Dosage Form
-
Strength
6MG
Approval Date
2025-11-25
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
4
Dosage Form
-
Strength
8MG
Approval Date
2025-11-25
Active Ingredient
PERAMPANEL
Application Number
218178
Product Number
4
Dosage Form
-
Strength
8MG
Approval Date
2025-11-25
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2025-11-25
Active Ingredient
PERAMPANEL
Application Number
218178
Product Number
5
Dosage Form
-
Strength
10MG
Approval Date
2025-11-25
Regulatory Status
RX
Drug Name
PERAMPANEL
Product Number
6
Dosage Form
-
Strength
12MG
Approval Date
2025-11-25
Active Ingredient
PERAMPANEL
Application Number
218178
Product Number
6
Dosage Form
-
Strength
12MG
Approval Date
2025-11-25
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-05-24
Active Ingredient
PIRFENIDONE
Application Number
212772
Product Number
1
Dosage Form
-
Strength
267MG
Approval Date
2022-05-24
Regulatory Status
RX
Drug Name
PIRFENIDONE
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-05-24
Active Ingredient
PIRFENIDONE
Application Number
212772
Product Number
2
Dosage Form
-
Strength
801MG
Approval Date
2022-05-24
Regulatory Status
RX
Drug Name
PLERIXAFOR
Product Number
1
Dosage Form
-
Strength
24MG/1.2ML (20MG/ML)
Approval Date
2023-07-24
Active Ingredient
PLERIXAFOR
Application Number
211901
Product Number
1
Dosage Form
-
Strength
24MG/1.2ML (20MG/ML)
Approval Date
2023-07-24
Regulatory Status
RX
Drug Name
POSACONAZOLE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-02-24
Active Ingredient
POSACONAZOLE
Application Number
218434
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-02-24
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-09-17
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
216727
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2024-09-17
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2024-09-17
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
216727
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2024-09-17
Regulatory Status
RX
Drug Name
PRAZOSIN HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-09-17
Active Ingredient
PRAZOSIN HYDROCHLORIDE
Application Number
216727
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2024-09-17
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
3
Dosage Form
-
Strength
75MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
4
Dosage Form
-
Strength
100MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
5
Dosage Form
-
Strength
150MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
6
Dosage Form
-
Strength
200MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
7
Dosage Form
-
Strength
225MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2019-07-19
Active Ingredient
PREGABALIN
Application Number
209357
Product Number
8
Dosage Form
-
Strength
300MG
Approval Date
2019-07-19
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
1
Dosage Form
-
Strength
82.5MG
Approval Date
2021-04-13
Active Ingredient
PREGABALIN
Application Number
213226
Product Number
1
Dosage Form
-
Strength
82.5MG
Approval Date
2021-04-13
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
2
Dosage Form
-
Strength
165MG
Approval Date
2021-04-13
Active Ingredient
PREGABALIN
Application Number
213226
Product Number
2
Dosage Form
-
Strength
165MG
Approval Date
2021-04-13
Regulatory Status
RX
Drug Name
PREGABALIN
Product Number
3
Dosage Form
-
Strength
330MG
Approval Date
2021-04-13
Active Ingredient
PREGABALIN
Application Number
213226
Product Number
3
Dosage Form
-
Strength
330MG
Approval Date
2021-04-13
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
218177
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
218177
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
PYRIDOSTIGMINE BROMIDE
Product Number
1
Dosage Form
-
Strength
60MG/5ML
Approval Date
2023-09-21
Active Ingredient
PYRIDOSTIGMINE BROMIDE
Application Number
216512
Product Number
1
Dosage Form
-
Strength
60MG/5ML
Approval Date
2023-09-21
Regulatory Status
RX
Drug Name
RIOCIGUAT
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2022-09-01
Active Ingredient
RIOCIGUAT
Application Number
211135
Product Number
1
Dosage Form
-
Strength
0.5MG
Approval Date
2022-09-01
Regulatory Status
RX
Drug Name
RIOCIGUAT
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2022-09-01
Active Ingredient
RIOCIGUAT
Application Number
211135
Product Number
2
Dosage Form
-
Strength
1MG
Approval Date
2022-09-01
Regulatory Status
RX
Drug Name
RIOCIGUAT
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2022-09-01
Active Ingredient
RIOCIGUAT
Application Number
211135
Product Number
3
Dosage Form
-
Strength
1.5MG
Approval Date
2022-09-01
Regulatory Status
RX
Drug Name
RIOCIGUAT
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2022-09-01
Active Ingredient
RIOCIGUAT
Application Number
211135
Product Number
4
Dosage Form
-
Strength
2MG
Approval Date
2022-09-01
Regulatory Status
RX
Drug Name
RIOCIGUAT
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2022-09-01
Active Ingredient
RIOCIGUAT
Application Number
211135
Product Number
5
Dosage Form
-
Strength
2.5MG
Approval Date
2022-09-01
Regulatory Status
RX
Drug Name
RIVAROXABAN
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-10-24
Active Ingredient
RIVAROXABAN
Application Number
208546
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2025-10-24
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
1
Dosage Form
-
Strength
250MCG
Approval Date
2022-09-07
Active Ingredient
ROFLUMILAST
Application Number
208256
Product Number
1
Dosage Form
-
Strength
250MCG
Approval Date
2022-09-07
Regulatory Status
RX
Drug Name
ROFLUMILAST
Product Number
2
Dosage Form
-
Strength
500MCG
Approval Date
2022-09-07
Active Ingredient
ROFLUMILAST
Application Number
208256
Product Number
2
Dosage Form
-
Strength
500MCG
Approval Date
2022-09-07
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-11-22
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
208898
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2017-11-22
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-11-22
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
208898
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2017-11-22
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-11-22
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
208898
Product Number
3
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2017-11-22
Regulatory Status
RX
Drug Name
ROSUVASTATIN CALCIUM
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-11-22
Active Ingredient
ROSUVASTATIN CALCIUM
Application Number
208898
Product Number
4
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2017-11-22
Regulatory Status
RX
Drug Name
RUFINAMIDE
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2025-04-15
Active Ingredient
RUFINAMIDE
Application Number
214817
Product Number
1
Dosage Form
-
Strength
40MG/ML
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2025-07-16
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213748
Product Number
1
Dosage Form
-
Strength
24MG;26MG
Approval Date
2025-07-16
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2025-07-16
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213748
Product Number
2
Dosage Form
-
Strength
49MG;51MG
Approval Date
2025-07-16
Regulatory Status
RX
Drug Name
SACUBITRIL AND VALSARTAN
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2025-07-16
Active Ingredient
SACUBITRIL; VALSARTAN
Application Number
213748
Product Number
3
Dosage Form
-
Strength
97MG;103MG
Approval Date
2025-07-16
Regulatory Status
RX
Drug Name
SAFINAMIDE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2024-12-31
Active Ingredient
SAFINAMIDE MESYLATE
Application Number
215978
Product Number
1
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2024-12-31
Regulatory Status
RX
Drug Name
SAFINAMIDE MESYLATE
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2024-12-31
Active Ingredient
SAFINAMIDE MESYLATE
Application Number
215978
Product Number
2
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2024-12-31
Regulatory Status
RX
Drug Name
SILDENAFIL CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2022-02-08
Active Ingredient
SILDENAFIL CITRATE
Application Number
214641
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/ML
Approval Date
2022-02-08
Regulatory Status
RX
Drug Name
SILODOSIN
Product Number
1
Dosage Form
-
Strength
4MG
Approval Date
2018-12-03
Active Ingredient
SILODOSIN
Application Number
210687
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
210687
Product Number
2
Dosage Form
-
Strength
8MG
Approval Date
2018-12-03
Regulatory Status
RX
Drug Name
SIROLIMUS
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-01-19
Active Ingredient
SIROLIMUS
Application Number
216728
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2023-01-19
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-05-20
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
210688
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2019-05-20
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-05-20
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
210688
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2019-05-20
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
214368
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
214368
Product Number
2
Dosage Form
-
Strength
EQ 500MG BASE/5ML (EQ 100MG BASE/ML)
Approval Date
2026-07-28
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2025-02-14
Active Ingredient
SUNITINIB MALATE
Application Number
214824
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG BASE
Approval Date
2025-02-14
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2025-02-14
Active Ingredient
SUNITINIB MALATE
Application Number
214824
Product Number
2
Dosage Form
-
Strength
EQ 25MG BASE
Approval Date
2025-02-14
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2025-02-14
Active Ingredient
SUNITINIB MALATE
Application Number
214824
Product Number
3
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2025-02-14
Regulatory Status
RX
Drug Name
SUNITINIB MALATE
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2025-02-14
Active Ingredient
SUNITINIB MALATE
Application Number
214824
Product Number
4
Dosage Form
-
Strength
EQ 50MG BASE
Approval Date
2025-02-14
Regulatory Status
RX
Drug Name
TASIMELTEON
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-01-12
Active Ingredient
TASIMELTEON
Application Number
211654
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2023-01-12
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2019-04-24
Active Ingredient
TERIFLUNOMIDE
Application Number
209623
Product Number
1
Dosage Form
-
Strength
7MG
Approval Date
2019-04-24
Regulatory Status
RX
Drug Name
TERIFLUNOMIDE
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2019-04-24
Active Ingredient
TERIFLUNOMIDE
Application Number
209623
Product Number
2
Dosage Form
-
Strength
14MG
Approval Date
2019-04-24
Regulatory Status
RX
Drug Name
THIOTEPA
Product Number
1
Dosage Form
-
Strength
15MG/VIAL
Approval Date
2020-03-04
Active Ingredient
THIOTEPA
Application Number
213049
Product Number
1
Dosage Form
-
Strength
15MG/VIAL
Approval Date
2020-03-04
Regulatory Status
RX
Drug Name
THIOTEPA
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2020-03-04
Active Ingredient
THIOTEPA
Application Number
213049
Product Number
2
Dosage Form
-
Strength
100MG/VIAL
Approval Date
2020-03-04
Regulatory Status
RX
Drug Name
TIAGABINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2021-11-16
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
214816
Product Number
1
Dosage Form
-
Strength
2MG
Approval Date
2021-11-16
Regulatory Status
RX
Drug Name
TIAGABINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2021-11-16
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
214816
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2021-11-16
Regulatory Status
RX
Drug Name
TIAGABINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
12MG
Approval Date
2021-11-16
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
214816
Product Number
3
Dosage Form
-
Strength
12MG
Approval Date
2021-11-16
Regulatory Status
RX
Drug Name
TIAGABINE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
2021-11-16
Active Ingredient
TIAGABINE HYDROCHLORIDE
Application Number
214816
Product Number
4
Dosage Form
-
Strength
16MG
Approval Date
2021-11-16
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2020-04-07
Active Ingredient
TICAGRELOR
Application Number
208596
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2020-04-07
Regulatory Status
RX
Drug Name
TICAGRELOR
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-10-28
Active Ingredient
TICAGRELOR
Application Number
208596
Product Number
2
Dosage Form
-
Strength
60MG
Approval Date
2025-10-28
Regulatory Status
RX
Drug Name
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE
Product Number
1
Dosage Form
-
Strength
EQ 6.14MG BASE;15MG
Approval Date
2025-01-08
Active Ingredient
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Application Number
214024
Product Number
1
Dosage Form
-
Strength
EQ 6.14MG BASE;15MG
Approval Date
2025-01-08
Regulatory Status
RX
Drug Name
TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE
Product Number
2
Dosage Form
-
Strength
EQ 8.19MG BASE;20MG
Approval Date
2025-01-08
Active Ingredient
TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE
Application Number
214024
Product Number
2
Dosage Form
-
Strength
EQ 8.19MG BASE;20MG
Approval Date
2025-01-08
Regulatory Status
RX
Drug Name
TOFACITINIB CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2026-06-03
Active Ingredient
TOFACITINIB CITRATE
Application Number
217298
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE/ML
Approval Date
2026-06-03
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
217299
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
217299
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
2026-06-03
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2023-06-21
Active Ingredient
TOLVAPTAN
Application Number
216949
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
2023-06-21
Regulatory Status
RX
Drug Name
TOLVAPTAN
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2023-06-21
Active Ingredient
TOLVAPTAN
Application Number
216949
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
2023-06-21
Regulatory Status
RX
Drug Name
TOREMIFENE CITRATE
Product Number
1
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2020-08-18
Active Ingredient
TOREMIFENE CITRATE
Application Number
212818
Product Number
1
Dosage Form
-
Strength
EQ 60MG BASE
Approval Date
2020-08-18
Regulatory Status
RX
Drug Name
TRIENTINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2019-05-22
Active Ingredient
TRIENTINE HYDROCHLORIDE
Application Number
211134
Product Number
1
Dosage Form
-
Strength
250MG
Approval Date
2019-05-22
Regulatory Status
RX
Drug Name
VALGANCICLOVIR HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2022-02-17
Active Ingredient
VALGANCICLOVIR HYDROCHLORIDE
Application Number
210169
Product Number
1
Dosage Form
-
Strength
50MG/ML
Approval Date
2022-02-17
Regulatory Status
RX
Drug Name
VIGABATRIN
Product Number
1
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2022-09-07
Active Ingredient
VIGABATRIN
Application Number
215363
Product Number
1
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2022-09-07
Regulatory Status
RX
Drug Name
ZIPRASIDONE MESYLATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2022-09-15
Active Ingredient
ZIPRASIDONE MESYLATE
Application Number
216091
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/VIAL
Approval Date
2022-09-15
Regulatory Status
RX
Drug Status Breakdown
252 total- RX
Official Source
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Drug Name
ABIRATERONE ACETATE
Application Number
210686
Product Number
1
Active Ingredient
ABIRATERONE ACETATE
Dosage Form
-
Strength
250MG
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
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