← 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