Annora Pharma RX
FDA Approved Drugs
Annora Pharma RX
FDA Approved Drugs Database
FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.
- Total Records 104
- Latest Approval Date Jul 07, 2026
- Data Source FDA
- First Approval Date Jul 01, 2002
Company Overview
Social Profiles
Company Snapshot
Annora Pharma RX
Sy. No. 261, Annaram Village, Gummadidal Mandal Sangareddy District. Telangana State – 502313
India
www.annorapharma.com/ info@annorapharma.com View on MapFDA Approved Drug Records ( 104 records )
Drug Name
AMINOCAPROIC ACID
Product Number
1
Dosage Form
-
Strength
0.25GM/ML
Approval Date
2022-11-04
Active Ingredient
AMINOCAPROIC ACID
Application Number
216464
Product Number
1
Dosage Form
-
Strength
0.25GM/ML
Approval Date
2022-11-04
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2023-05-31
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
216800
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2023-05-31
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2023-05-31
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
216800
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2023-05-31
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2023-05-31
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
216800
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2023-05-31
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2025-10-01
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
217898
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2025-10-01
Regulatory Status
RX
Drug Name
BUPROPION HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-10-01
Active Ingredient
BUPROPION HYDROCHLORIDE
Application Number
217898
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-10-01
Regulatory Status
RX
Drug Name
COLCHICINE
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2024-04-29
Active Ingredient
COLCHICINE
Application Number
217620
Product Number
1
Dosage Form
-
Strength
0.6MG
Approval Date
2024-04-29
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2025-01-21
Active Ingredient
DARUNAVIR
Application Number
216168
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2025-01-21
Regulatory Status
RX
Drug Name
DARUNAVIR
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2025-01-21
Active Ingredient
DARUNAVIR
Application Number
216168
Product Number
2
Dosage Form
-
Strength
800MG
Approval Date
2025-01-21
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2021-05-14
Active Ingredient
DEFERASIROX
Application Number
214341
Product Number
1
Dosage Form
-
Strength
90MG
Approval Date
2021-05-14
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2021-05-14
Active Ingredient
DEFERASIROX
Application Number
214341
Product Number
2
Dosage Form
-
Strength
180MG
Approval Date
2021-05-14
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
360MG
Approval Date
2021-05-14
Active Ingredient
DEFERASIROX
Application Number
214341
Product Number
3
Dosage Form
-
Strength
360MG
Approval Date
2021-05-14
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
1
Dosage Form
-
Strength
180MG
Approval Date
2022-09-22
Active Ingredient
DEFERASIROX
Application Number
216229
Product Number
1
Dosage Form
-
Strength
180MG
Approval Date
2022-09-22
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2022-09-22
Active Ingredient
DEFERASIROX
Application Number
216229
Product Number
2
Dosage Form
-
Strength
360MG
Approval Date
2022-09-22
Regulatory Status
RX
Drug Name
DEFERASIROX
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2023-03-16
Active Ingredient
DEFERASIROX
Application Number
216229
Product Number
3
Dosage Form
-
Strength
90MG
Approval Date
2023-03-16
Regulatory Status
RX
Drug Name
DESOGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.15MG,N/A;0.02MG,0.01MG
Approval Date
2026-07-07
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
219670
Product Number
1
Dosage Form
-
Strength
0.15MG,N/A;0.02MG,0.01MG
Approval Date
2026-07-07
Regulatory Status
RX
Drug Name
DESOGESTREL AND ETHINYL ESTRADIOL
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG
Approval Date
2026-03-18
Active Ingredient
DESOGESTREL; ETHINYL ESTRADIOL
Application Number
219761
Product Number
1
Dosage Form
-
Strength
0.15MG;0.03MG
Approval Date
2026-03-18
Regulatory Status
RX
Drug Name
DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM
Product Number
1
Dosage Form
-
Strength
66%;10%
Approval Date
2023-11-17
Active Ingredient
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
Application Number
215049
Product Number
1
Dosage Form
-
Strength
66%;10%
Approval Date
2023-11-17
Regulatory Status
RX
Drug Name
DICLOFENAC POTASSIUM
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-03-04
Active Ingredient
DICLOFENAC POTASSIUM
Application Number
215375
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2022-03-04
Regulatory Status
RX
Drug Name
DICYCLOMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-05-07
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
217566
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-05-07
Regulatory Status
RX
Drug Name
DICYCLOMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-07-01
Active Ingredient
DICYCLOMINE HYDROCHLORIDE
Application Number
218018
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2024-07-01
Regulatory Status
RX
Drug Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
12.5MG/5ML
Approval Date
2026-06-17
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Application Number
219470
Product Number
1
Dosage Form
-
Strength
12.5MG/5ML
Approval Date
2026-06-17
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2023-09-26
Active Ingredient
DIVALPROEX SODIUM
Application Number
215527
Product Number
1
Dosage Form
-
Strength
EQ 250MG VALPROIC ACID
Approval Date
2023-09-26
Regulatory Status
RX
Drug Name
DIVALPROEX SODIUM
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2023-09-26
Active Ingredient
DIVALPROEX SODIUM
Application Number
215527
Product Number
2
Dosage Form
-
Strength
EQ 500MG VALPROIC ACID
Approval Date
2023-09-26
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2025-07-07
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
219143
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE
Approval Date
2025-07-07
Regulatory Status
RX
Drug Name
ELETRIPTAN HYDROBROMIDE
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2025-07-07
Active Ingredient
ELETRIPTAN HYDROBROMIDE
Application Number
219143
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2025-07-07
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG ACID/PACKET
Approval Date
2024-04-18
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
216620
Product Number
1
Dosage Form
-
Strength
EQ 12.5MG ACID/PACKET
Approval Date
2024-04-18
Regulatory Status
RX
Drug Name
ELTROMBOPAG OLAMINE
Product Number
2
Dosage Form
-
Strength
EQ 25MG ACID/PACKET
Approval Date
2024-04-18
Active Ingredient
ELTROMBOPAG OLAMINE
Application Number
216620
Product Number
2
Dosage Form
-
Strength
EQ 25MG ACID/PACKET
Approval Date
2024-04-18
Regulatory Status
RX
Drug Name
ENALAPRIL MALEATE
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-02-24
Active Ingredient
ENALAPRIL MALEATE
Application Number
214467
Product Number
1
Dosage Form
-
Strength
1MG/ML
Approval Date
2022-02-24
Regulatory Status
RX
Drug Name
EPLERENONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-06-02
Active Ingredient
EPLERENONE
Application Number
213812
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2023-06-02
Regulatory Status
RX
Drug Name
EPLERENONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-06-02
Active Ingredient
EPLERENONE
Application Number
213812
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2023-06-02
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2021-11-04
Active Ingredient
FAMOTIDINE
Application Number
215767
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2021-11-04
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2021-11-04
Active Ingredient
FAMOTIDINE
Application Number
215767
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2021-11-04
Regulatory Status
RX
Drug Name
FAMOTIDINE
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2023-08-17
Active Ingredient
FAMOTIDINE
Application Number
217330
Product Number
1
Dosage Form
-
Strength
40MG/5ML
Approval Date
2023-08-17
Regulatory Status
RX
Drug Name
FLUVOXAMINE MALEATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-07-30
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
217024
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2025-07-30
Regulatory Status
RX
Drug Name
FLUVOXAMINE MALEATE
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-07-30
Active Ingredient
FLUVOXAMINE MALEATE
Application Number
217024
Product Number
2
Dosage Form
-
Strength
150MG
Approval Date
2025-07-30
Regulatory Status
RX
Drug Name
FOSTAMATINIB DISODIUM
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-06-17
Active Ingredient
FOSTAMATINIB DISODIUM
Application Number
217329
Product Number
1
Dosage Form
-
Strength
EQ 100MG BASE
Approval Date
2026-06-17
Regulatory Status
RX
Drug Name
FOSTAMATINIB DISODIUM
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-06-17
Active Ingredient
FOSTAMATINIB DISODIUM
Application Number
217329
Product Number
2
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2026-06-17
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2024-01-17
Active Ingredient
GABAPENTIN
Application Number
217682
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2024-01-17
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2024-02-26
Active Ingredient
GABAPENTIN
Application Number
218075
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2024-02-26
Regulatory Status
RX
Drug Name
GABAPENTIN
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
2024-02-26
Active Ingredient
GABAPENTIN
Application Number
218075
Product Number
2
Dosage Form
-
Strength
600MG
Approval Date
2024-02-26
Regulatory Status
RX
Drug Name
GLYCOPYRROLATE
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
2022-07-05
Active Ingredient
GLYCOPYRROLATE
Application Number
213698
Product Number
1
Dosage Form
-
Strength
1MG/5ML
Approval Date
2022-07-05
Regulatory Status
RX
Drug Name
INDOMETHACIN
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2025-07-03
Active Ingredient
INDOMETHACIN
Application Number
216905
Product Number
1
Dosage Form
-
Strength
50MG
Approval Date
2025-07-03
Regulatory Status
RX
Drug Name
ITRACONAZOLE
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2020-09-01
Active Ingredient
ITRACONAZOLE
Application Number
212239
Product Number
1
Dosage Form
-
Strength
10MG/ML
Approval Date
2020-09-01
Regulatory Status
RX
Drug Name
IVABRADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2022-10-05
Active Ingredient
IVABRADINE HYDROCHLORIDE
Application Number
213366
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
2022-10-05
Regulatory Status
RX
Drug Name
IVABRADINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2022-10-05
Active Ingredient
IVABRADINE HYDROCHLORIDE
Application Number
213366
Product Number
2
Dosage Form
-
Strength
EQ 7.5MG BASE
Approval Date
2022-10-05
Regulatory Status
RX
Drug Name
L-GLUTAMINE
Product Number
1
Dosage Form
-
Strength
5GM/PACKET
Approval Date
2026-05-26
Active Ingredient
L-GLUTAMINE
Application Number
219722
Product Number
1
Dosage Form
-
Strength
5GM/PACKET
Approval Date
2026-05-26
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2002-07-01
Active Ingredient
LISINOPRIL
Application Number
75903
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2002-07-01
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2002-07-01
Active Ingredient
LISINOPRIL
Application Number
75903
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2002-07-01
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2002-07-01
Active Ingredient
LISINOPRIL
Application Number
75903
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2002-07-01
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2002-07-01
Active Ingredient
LISINOPRIL
Application Number
75903
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2002-07-01
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2002-07-01
Active Ingredient
LISINOPRIL
Application Number
75903
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2002-07-01
Regulatory Status
RX
Drug Name
LISINOPRIL
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2002-07-01
Active Ingredient
LISINOPRIL
Application Number
75903
Product Number
6
Dosage Form
-
Strength
40MG
Approval Date
2002-07-01
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-08-21
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
218174
Product Number
1
Dosage Form
-
Strength
20MG
Approval Date
2024-08-21
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2024-08-21
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
218174
Product Number
2
Dosage Form
-
Strength
40MG
Approval Date
2024-08-21
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2024-08-21
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
218174
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
2024-08-21
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2024-08-21
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
218174
Product Number
4
Dosage Form
-
Strength
80MG
Approval Date
2024-08-21
Regulatory Status
RX
Drug Name
LURASIDONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2024-08-21
Active Ingredient
LURASIDONE HYDROCHLORIDE
Application Number
218174
Product Number
5
Dosage Form
-
Strength
120MG
Approval Date
2024-08-21
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2020-03-19
Active Ingredient
MESALAMINE
Application Number
213377
Product Number
1
Dosage Form
-
Strength
1GM
Approval Date
2020-03-19
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
1.2GM
Approval Date
2024-02-05
Active Ingredient
MESALAMINE
Application Number
216334
Product Number
1
Dosage Form
-
Strength
1.2GM
Approval Date
2024-02-05
Regulatory Status
RX
Drug Name
MESALAMINE
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2025-08-13
Active Ingredient
MESALAMINE
Application Number
219864
Product Number
1
Dosage Form
-
Strength
375MG
Approval Date
2025-08-13
Regulatory Status
RX
Drug Name
METFORMIN HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
500MG/5ML
Approval Date
2025-03-13
Active Ingredient
METFORMIN HYDROCHLORIDE
Application Number
215008
Product Number
1
Dosage Form
-
Strength
500MG/5ML
Approval Date
2025-03-13
Regulatory Status
RX
Drug Name
MEXILETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2022-11-09
Active Ingredient
MEXILETINE HYDROCHLORIDE
Application Number
216463
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2022-11-09
Regulatory Status
RX
Drug Name
MEXILETINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2022-11-09
Active Ingredient
MEXILETINE HYDROCHLORIDE
Application Number
216463
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
2022-11-09
Regulatory Status
RX
Drug Name
MEXILETINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2022-11-09
Active Ingredient
MEXILETINE HYDROCHLORIDE
Application Number
216463
Product Number
3
Dosage Form
-
Strength
250MG
Approval Date
2022-11-09
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2025-10-02
Active Ingredient
MIRTAZAPINE
Application Number
219721
Product Number
1
Dosage Form
-
Strength
7.5MG
Approval Date
2025-10-02
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2025-10-02
Active Ingredient
MIRTAZAPINE
Application Number
219721
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2025-10-02
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2025-10-02
Active Ingredient
MIRTAZAPINE
Application Number
219721
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2025-10-02
Regulatory Status
RX
Drug Name
MIRTAZAPINE
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2025-10-02
Active Ingredient
MIRTAZAPINE
Application Number
219721
Product Number
4
Dosage Form
-
Strength
45MG
Approval Date
2025-10-02
Regulatory Status
RX
Drug Name
NABUMETONE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2011-01-12
Active Ingredient
NABUMETONE
Application Number
90445
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2011-01-12
Regulatory Status
RX
Drug Name
NABUMETONE
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2011-01-12
Active Ingredient
NABUMETONE
Application Number
90445
Product Number
2
Dosage Form
-
Strength
750MG
Approval Date
2011-01-12
Regulatory Status
RX
Drug Name
NIMODIPINE
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2024-07-09
Active Ingredient
NIMODIPINE
Application Number
216937
Product Number
1
Dosage Form
-
Strength
3MG/ML
Approval Date
2024-07-09
Regulatory Status
RX
Drug Name
NITAZOXANIDE
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2025-04-15
Active Ingredient
NITAZOXANIDE
Application Number
218701
Product Number
1
Dosage Form
-
Strength
500MG
Approval Date
2025-04-15
Regulatory Status
RX
Drug Name
NITROFURANTOIN
Product Number
1
Dosage Form
-
Strength
25MG/5ML
Approval Date
2025-07-02
Active Ingredient
NITROFURANTOIN
Application Number
219495
Product Number
1
Dosage Form
-
Strength
25MG/5ML
Approval Date
2025-07-02
Regulatory Status
RX
Drug Name
OXCARBAZEPINE
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2022-01-11
Active Ingredient
OXCARBAZEPINE
Application Number
215939
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2022-01-11
Regulatory Status
RX
Drug Name
OXCARBAZEPINE
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2022-01-11
Active Ingredient
OXCARBAZEPINE
Application Number
215939
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2022-01-11
Regulatory Status
RX
Drug Name
OXCARBAZEPINE
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2022-01-11
Active Ingredient
OXCARBAZEPINE
Application Number
215939
Product Number
3
Dosage Form
-
Strength
600MG
Approval Date
2022-01-11
Regulatory Status
RX
Drug Name
PANTOPRAZOLE SODIUM
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2023-10-27
Active Ingredient
PANTOPRAZOLE SODIUM
Application Number
216139
Product Number
1
Dosage Form
-
Strength
EQ 40MG BASE
Approval Date
2023-10-27
Regulatory Status
RX
Drug Name
PAROXETINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2026-03-05
Active Ingredient
PAROXETINE HYDROCHLORIDE
Application Number
219954
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2026-03-05
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2014-04-07
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
204133
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE
Approval Date
2014-04-07
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2014-04-07
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
204133
Product Number
2
Dosage Form
-
Strength
EQ 30MG BASE
Approval Date
2014-04-07
Regulatory Status
RX
Drug Name
PIOGLITAZONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2014-04-07
Active Ingredient
PIOGLITAZONE HYDROCHLORIDE
Application Number
204133
Product Number
3
Dosage Form
-
Strength
EQ 45MG BASE
Approval Date
2014-04-07
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2022-11-02
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
216446
Product Number
1
Dosage Form
-
Strength
12.5MG
Approval Date
2022-11-02
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2022-11-02
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
216446
Product Number
2
Dosage Form
-
Strength
25MG
Approval Date
2022-11-02
Regulatory Status
RX
Drug Name
PRUCALOPRIDE SUCCINATE
Product Number
1
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-06-24
Active Ingredient
PRUCALOPRIDE SUCCINATE
Application Number
219160
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
219160
Product Number
2
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2025-06-24
Regulatory Status
RX
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/PACKET
Approval Date
2022-08-18
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
215420
Product Number
1
Dosage Form
-
Strength
100MG/PACKET
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2022-08-18
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
215420
Product Number
2
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2022-08-18
Regulatory Status
RX
Drug Name
SAPROPTERIN DIHYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2022-08-23
Active Ingredient
SAPROPTERIN DIHYDROCHLORIDE
Application Number
215534
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
2022-08-23
Regulatory Status
RX
Drug Name
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Product Number
1
Dosage Form
-
Strength
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Approval Date
2024-10-18
Active Ingredient
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE
Application Number
212903
Product Number
1
Dosage Form
-
Strength
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Approval Date
2024-10-18
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-06-15
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
215761
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2022-06-15
Regulatory Status
RX
Drug Name
SOLIFENACIN SUCCINATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-06-15
Active Ingredient
SOLIFENACIN SUCCINATE
Application Number
215761
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2022-06-15
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-07-25
Active Ingredient
SPIRONOLACTONE
Application Number
217761
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
2025-07-25
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-07-25
Active Ingredient
SPIRONOLACTONE
Application Number
217761
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
2025-07-25
Regulatory Status
RX
Drug Name
SPIRONOLACTONE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2025-07-25
Active Ingredient
SPIRONOLACTONE
Application Number
217761
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
2025-07-25
Regulatory Status
RX
Drug Name
THEOPHYLLINE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2023-09-08
Active Ingredient
THEOPHYLLINE
Application Number
217422
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2023-09-08
Regulatory Status
RX
Drug Name
THEOPHYLLINE
Product Number
2
Dosage Form
-
Strength
450MG
Approval Date
2023-09-08
Active Ingredient
THEOPHYLLINE
Application Number
217422
Product Number
2
Dosage Form
-
Strength
450MG
Approval Date
2023-09-08
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2019-07-08
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
212277
Product Number
1
Dosage Form
-
Strength
EQ 37.5MG BASE
Approval Date
2019-07-08
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2019-07-08
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
212277
Product Number
2
Dosage Form
-
Strength
EQ 75MG BASE
Approval Date
2019-07-08
Regulatory Status
RX
Drug Name
VENLAFAXINE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2019-07-08
Active Ingredient
VENLAFAXINE HYDROCHLORIDE
Application Number
212277
Product Number
3
Dosage Form
-
Strength
EQ 150MG BASE
Approval Date
2019-07-08
Regulatory Status
RX
Drug Name
VIGABATRIN
Product Number
1
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2021-01-26
Active Ingredient
VIGABATRIN
Application Number
213519
Product Number
1
Dosage Form
-
Strength
500MG/PACKET
Approval Date
2021-01-26
Regulatory Status
RX
Drug Name
ZAFIRLUKAST
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-09-10
Active Ingredient
ZAFIRLUKAST
Application Number
212475
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2020-09-10
Regulatory Status
RX
Drug Name
ZAFIRLUKAST
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-09-10
Active Ingredient
ZAFIRLUKAST
Application Number
212475
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2020-09-10
Regulatory Status
RX
Drug Name
ZILEUTON
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2022-10-11
Active Ingredient
ZILEUTON
Application Number
215742
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
2022-10-11
Regulatory Status
RX
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Drug Status Breakdown
104 total- RX
Official Source
FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.
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Drug Name
AMINOCAPROIC ACID
Application Number
216464
Product Number
1
Active Ingredient
AMINOCAPROIC ACID
Dosage Form
-
Strength
0.25GM/ML
FDA Approved Drug Data
Approved drug product information
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