Naproxen Sodium

ANDA 74495, held by Sandoz. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74495 (Naproxen Sodium), held by Sandoz, was first approved by FDA on Dec 5, 1994, with 11 approved supplements and 0 published complete response letters.

First approved: Dec 5, 1994
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Dec 5, 1994	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 12 submissions, including labeling and manufacturing supplements


Aug 28, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Aug 28, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Aug 28, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Dec 4, 2000	Supplement 9Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 8Manufacturing	Approved	None posted
Mar 27, 2000	Supplement 7Manufacturing	Approved	None posted
Mar 27, 2000	Supplement 6Manufacturing	Approved	None posted
Mar 27, 2000	Supplement 5Manufacturing	Approved	None posted
Jun 24, 1996	Supplement 3Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 4Manufacturing	Approved	None posted
Jan 19, 1996	Supplement 2Labeling	Approved	None posted
Dec 5, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74495
Drugs@FDA: Overview at FDA
Company: Sandoz

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