← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-12-10
Drug application
- FDA Application #
ANDA219161- 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
- Prescription
- Sponsor
- NOVITIUM PHARMA
- Manufacturer
- ANI Pharmaceuticals, Inc.
- First approval
- 2025-12-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown