← FDA Drug Approvals (Drugs@FDA)
OMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS LTD · Approved 2009-06-05
Drug application
- FDA Application #
ANDA078878- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- OMEPRAZOLE MAGNESIUM
- Generic name
- OMEPRAZOLE MAGNESIUM
- Active ingredients
- OMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DR REDDYS LABS LTD
- Manufacturer
- Gericare Pharmaceuticals
- First approval
- 2009-06-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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