Naproxen

ANDA 74207, held by Teva Pharms. Naproxen.

As of Nov 14, 2026, ANDA 74207 (Naproxen), held by Teva Pharms, was first approved by FDA on Dec 21, 1993, with 12 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Dec 21, 1993	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 13 submissions, including labeling and manufacturing supplements


Mar 23, 1999	Supplement 12Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 11Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 10Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 9Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 8Manufacturing	Approved	None posted
Dec 15, 1997	Supplement 6Manufacturing	Approved	None posted
Apr 8, 1997	Supplement 7Manufacturing	Approved	None posted
Apr 8, 1997	Supplement 4Manufacturing	Approved	None posted
Apr 8, 1997	Supplement 3Manufacturing	Approved	None posted
Jan 7, 1997	Supplement 5Manufacturing	Approved	None posted
May 31, 1996	Supplement 2Manufacturing	Approved	None posted
Jun 14, 1995	Supplement 1Manufacturing	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74207
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