Naproxen Sodium

ANDA 74142, held by Teva. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74142 (Naproxen Sodium), held by Teva, was first approved by FDA on Dec 21, 1993, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 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 11 submissions, including labeling and manufacturing supplements


Jan 24, 2026	Supplement 9Labeling · Standard review	Approved	None posted
Jan 24, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Jan 24, 2026	Supplement 11Labeling · Standard review	Approved	None posted
Oct 15, 1999	Supplement 7Manufacturing	Approved	None posted
Aug 6, 1998	Supplement 6Manufacturing	Approved	None posted
Jun 23, 1997	Supplement 5Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 3Manufacturing	Approved	None posted
Oct 30, 1996	Supplement 4Manufacturing	Approved	None posted
Oct 12, 1995	Supplement 2Labeling	Approved	None posted
Jun 20, 1994	Supplement 1Manufacturing	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74142
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