← FDA Drug Approvals (Drugs@FDA)

NAPROXEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2024-06-12

Drug application

FDA Application #

ANDA218497

Application type

Abbreviated New Drug Application (Generic)

Brand name

NAPROXEN

Generic name

NAPROXEN

Active ingredients

NAPROXEN

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2024-06-12

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown