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ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CSPC OUYI · Approved 2020-10-02
Drug application
- FDA Application #
ANDA212949- 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
- CSPC OUYI
- Manufacturer
- Rising Pharma Holdings, Inc.
- First approval
- 2020-10-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown