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ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS NY · Approved 2019-04-10
Drug application
- FDA Application #
ANDA209647- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ESOMEPRAZOLE MAGNESIUM
- Generic name
- Esomeprazole Magnesium
- Active ingredients
- ESOMEPRAZOLE MAGNESIUM
- Dosage form
- CAPSULE, DELAYED REL PELLETS
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- AMNEAL PHARMS NY
- First approval
- 2019-04-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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