Naproxen Sodium

ANDA 74289, held by Teva Pharms. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74289 (Naproxen Sodium), held by Teva Pharms, was first approved by FDA on Jan 27, 1994, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 27, 1994
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 27, 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 8 submissions, including labeling and manufacturing supplements


Mar 29, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Mar 29, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Mar 23, 1999	Supplement 5Manufacturing	Approved	None posted
Oct 18, 1996	Supplement 4Labeling	Approved	None posted
May 31, 1996	Supplement 3Manufacturing	Approved	None posted
Mar 22, 1996	Supplement 2Labeling	Approved	None posted
Jun 28, 1994	Supplement 1Manufacturing	Approved	None posted
Jan 27, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74289
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceuticals

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