← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS · Approved 2024-05-09
Drug application
- FDA Application #
ANDA217784- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OMEPRAZOLE AND SODIUM BICARBONATE
- Generic name
- OMEPRAZOLE AND SODIUM BICARBONATE
- Active ingredients
- OMEPRAZOLE; SODIUM BICARBONATE
- Dosage form
- FOR SUSPENSION
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DR REDDYS
- Manufacturer
- Dr. Reddy's Laboratories Inc.,
- First approval
- 2024-05-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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