Naproxen

ANDA 74163, held by Watson Labs Teva. Naproxen.

As of Nov 14, 2026, ANDA 74163 (Naproxen), held by Watson Labs Teva, was first approved by FDA on Feb 10, 1995, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 10, 1995
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
Feb 10, 1995	Original application	Approved	None posted

Products

3 strengths and forms


Naproxen250MG · tablet;oral	Naproxen	Discontinued
Naproxen375MG · tablet;oral	Naproxen	Discontinued
Naproxen500MG · tablet;oral	Naproxen	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Aug 24, 2001	Supplement 8Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 9Manufacturing	Approved	None posted
Feb 3, 2000	Supplement 7Manufacturing	Approved	None posted
Feb 3, 2000	Supplement 6Manufacturing	Approved	None posted
Feb 3, 2000	Supplement 5Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 3Manufacturing	Approved	None posted
Mar 4, 1999	Supplement 2Manufacturing	Approved	None posted
Jul 13, 1995	Supplement 1Labeling	Approved	None posted
Feb 10, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74163
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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