Naproxen Sodium

ANDA 78432, held by Amneal Pharms Ny. Naproxen Sodium.

As of Nov 15, 2026, ANDA 78432 (Naproxen Sodium), held by Amneal Pharms Ny, was first approved by FDA on Apr 25, 2007, with 8 approved supplements and 0 published complete response letters.

First approved: Apr 25, 2007
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Apr 25, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Naproxen SodiumEQ 250MG BASE · tablet;oral	Naproxen Sodium	Discontinued
Naproxen SodiumEQ 500MG BASE · tablet;oral	Naproxen Sodium	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Jun 2, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Jun 2, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Jun 2, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Jun 2, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Dec 3, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Dec 3, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Dec 3, 2019	Supplement 4Labeling · Standard review	Approved	None posted
May 4, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Apr 25, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78432
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