Naproxen

ANDA 74410, held by Chartwell Molecules. Naproxen.

As of Nov 14, 2026, ANDA 74410 (Naproxen), held by Chartwell Molecules, was first approved by FDA on Apr 28, 1995, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 28, 1995
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 28, 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 12 submissions, including labeling and manufacturing supplements


Jan 9, 2017	Supplement 24Labeling · Standard review	Approved	None posted
Feb 17, 2006	Supplement 14Labeling	Approved	None posted
Jan 31, 2006	Supplement 13Labeling	Approved	None posted
Nov 19, 2002	Supplement 8Labeling	Approved	None posted
Nov 19, 2002	Supplement 7Manufacturing	Approved	None posted
Mar 19, 2002	Supplement 6Manufacturing	Approved	None posted
Oct 9, 2001	Supplement 4Manufacturing	Approved	None posted
Oct 9, 2001	Supplement 3Manufacturing	Approved	None posted
Aug 27, 2001	Supplement 5Manufacturing	Approved	None posted
Nov 24, 1999	Supplement 2Manufacturing	Approved	None posted
Mar 4, 1997	Supplement 1Manufacturing	Approved	None posted
Apr 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74410
Drugs@FDA: Overview at FDA
Company: Chartwell Molecules

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