← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2019-02-11
Drug application
- FDA Application #
ANDA210070
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OMEPRAZOLE
- Generic name
- Omeprazole
- Active ingredients
- OMEPRAZOLE
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- APOTEX
- First approval
- 2019-02-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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