← FDA Drug Approvals (Drugs@FDA)
PRILOSEC
NDA · New Drug Application · Sponsor: AZURITY · Approved 2008-03-20
Drug application
- FDA Application #
NDA022056
- Application type
- New Drug Application
- Brand name
- PRILOSEC
- Generic name
- OMEPRAZOLE MAGNESIUM
- Active ingredients
- OMEPRAZOLE MAGNESIUM
- Dosage form
- FOR SUSPENSION, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AZURITY
- Manufacturer
- Covis Pharma US, Inc
- First approval
- 2008-03-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown