Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204228
Company: AJANTA PHARMA LTD
Company: AJANTA PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | AB | No | No |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | AB | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
07/15/2016 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204228Orig1s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/15/2023 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
11/15/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
11/15/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
02/24/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
02/24/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
02/24/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
OMEPRAZOLE AND SODIUM BICARBONATE
CAPSULE;ORAL; 20MG;1.1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 204228 | AJANTA PHARMA LTD |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 212587 | ANDA REPOSITORY |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 204922 | AUROLIFE PHARMA LLC |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 204068 | DR REDDYS |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 207476 | SCIEGEN PHARMS INC |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 203290 | ZYDUS PHARMS |
CAPSULE;ORAL; 40MG;1.1GM
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 204228 | AJANTA PHARMA LTD |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 212587 | ANDA REPOSITORY |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 204922 | AUROLIFE PHARMA LLC |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 204068 | DR REDDYS |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 207476 | SCIEGEN PHARMS INC |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG;1.1GM | CAPSULE;ORAL | Prescription | No | AB | 203290 | ZYDUS PHARMS |