← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE
NDA · New Drug Application · Sponsor: DEXCEL · Approved 2017-07-05
Drug application
- FDA Application #
NDA209400- Application type
- New Drug Application
- Brand name
- OMEPRAZOLE
- Generic name
- OMEPRAZOLE
- Active ingredients
- OMEPRAZOLE
- Dosage form
- TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DEXCEL
- Manufacturer
- BJWC
- First approval
- 2017-07-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown