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NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2022-08-24
Drug application
- FDA Application #
ANDA204470- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Generic name
- Esomeprazole Magnesium
- Active ingredients
- ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- ACTAVIS LABS FL INC
- First approval
- 2022-08-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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