← FDA Drug Approvals (Drugs@FDA)
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2022-10-06
Drug application
- FDA Application #
ANDA213699
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Generic name
- NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
- Active ingredients
- ESOMEPRAZOLE MAGNESIUM; NAPROXEN
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- AJANTA PHARMA LTD
- Manufacturer
- Ajanta Pharma USA Inc.
- First approval
- 2022-10-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown