Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205545
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/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
07/27/2016 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/26/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
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12/26/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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12/26/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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04/06/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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04/06/2020 | SUPPL-4 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/06/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
OMEPRAZOLE AND SODIUM BICARBONATE
FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
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/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 205545 | AJANTA PHARMA LTD |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 079182 | STRIDES PHARMA |
FOR SUSPENSION;ORAL; 40MG/PACKET;1.68GM/PACKET
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/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 205545 | AJANTA PHARMA LTD |
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 40MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 079182 | STRIDES PHARMA |