← FDA Drug Approvals (Drugs@FDA)
PRILOSEC OTC
NDA · New Drug Application · Sponsor: ASTRAZENECA · Approved 2003-06-20
Drug application
- FDA Application #
NDA021229- Application type
- New Drug Application
- Brand name
- PRILOSEC OTC
- Generic name
- OMEPRAZOLE MAGNESIUM
- Active ingredients
- OMEPRAZOLE MAGNESIUM
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- ASTRAZENECA
- Manufacturer
- The Procter & Gamble Manufacturing Company
- First approval
- 2003-06-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown