Naproxen Sodium

ANDA 79096, held by Amneal Pharms Ny. Naproxen Sodium.

As of Nov 15, 2026, ANDA 79096 (Naproxen Sodium), held by Amneal Pharms Ny, was first approved by FDA on Dec 16, 2008, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 16, 2008
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves minor aches and pains due to: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Dec 16, 2008	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naproxen Sodium220MG · tablet;oral	Naproxen Sodium	OTC

All 5 submissions, including labeling and manufacturing supplements


Feb 24, 2015	Supplement 2Manufacturing	Approved	None posted
Feb 24, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Aug 11, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Jan 31, 2011	Supplement 4Labeling	Approved	None posted
Dec 16, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 79096
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters