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ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2017-10-20
Drug application
- FDA Application #
ANDA208333- 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
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2017-10-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown