← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MARKSANS PHARMA · Approved 2025-08-07
Drug application
- FDA Application #
ANDA218829- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OMEPRAZOLE MAGNESIUM
- Generic name
- OMEPRAZOLE 20 MG
- Active ingredients
- OMEPRAZOLE MAGNESIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- MARKSANS PHARMA
- Manufacturer
- MARKSANS PHARMA LIMITED
- First approval
- 2025-08-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown