Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 217784
Company: DR REDDYS
Company: DR REDDYS
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 | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
05/09/2024 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
OMEPRAZOLE AND SODIUM BICARBONATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
FOR SUSPENSION;ORAL; 20MG/PACKET;1.68GM/PACKET
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
OMEPRAZOLE AND SODIUM BICARBONATE | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Over-the-counter | No | 217784 | DR REDDYS |
ZEGERID OTC | OMEPRAZOLE; SODIUM BICARBONATE | 20MG/PACKET;1.68GM/PACKET | FOR SUSPENSION;ORAL | Over-the-counter | Yes | 022283 | RILEY CONSUMER |