Naproxen Sodium

ANDA 74198, held by Teva. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74198 (Naproxen Sodium), held by Teva, was first approved by FDA on Dec 21, 1993, with 20 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Dec 21, 1993	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 21 submissions, including labeling and manufacturing supplements


Aug 13, 2020	Supplement 40Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 38Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 37Labeling · Standard review	Approved	None posted
Apr 15, 2015	Supplement 35Labeling · Standard review	Approved	None posted
Jun 28, 2008	Supplement 30Labeling	Approved	None posted
May 19, 2006	Supplement 28Labeling	Approved	None posted
Feb 17, 2006	Supplement 27Labeling	Approved	None posted
Aug 22, 2001	Supplement 17Manufacturing	Approved	None posted
May 24, 2000	Supplement 16Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 14Manufacturing	Approved	None posted
Dec 2, 1999	Supplement 13Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 9Manufacturing	Approved	None posted
Feb 12, 1999	Supplement 8Manufacturing	Approved	None posted
Jun 9, 1998	Supplement 7Manufacturing	Approved	None posted
Jan 15, 1997	Supplement 6Manufacturing	Approved	None posted
Jan 15, 1997	Supplement 5Manufacturing	Approved	None posted
Jan 15, 1997	Supplement 4Manufacturing	Approved	None posted
Aug 16, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 17, 1995	Supplement 2Labeling	Approved	None posted
Feb 17, 1995	Supplement 1Manufacturing	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74198
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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