← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS · Approved 2018-03-16
Drug application
- FDA Application #
ANDA203345- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OMEPRAZOLE AND SODIUM BICARBONATE
- Generic name
- Omeprazole
- Active ingredients
- OMEPRAZOLE; SODIUM BICARBONATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- ZYDUS
- First approval
- 2018-03-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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