← FDA Drug Approvals (Drugs@FDA)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS LTD · Approved 2018-09-04
Drug application
- FDA Application #
ANDA202461- 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
- None (Tentative Approval)
- Sponsor
- DR REDDYS LABS LTD
- First approval
- 2018-09-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown