Naproxen

As of Nov 14, 2026, ANDA 74140 (Naproxen), held by Granules, was first approved by FDA on Dec 21, 1993, with 28 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Naproxen tablets are indicated for: the relief of the signs and symptoms of:

rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets are also indicated for: the relief of signs and symptoms of:
tendonitis
bursitis
acute gout the management of:
pain
primary dysmenorrhea

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Dec 21, 1993	Original application	Approved	None posted

Products

3 strengths and forms


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

All 29 submissions, including labeling and manufacturing supplements


Mar 11, 2022	Supplement 42Manufacturing · Standard review	Approved	None posted
Mar 11, 2022	Supplement 41Labeling · Standard review	Approved	None posted
Mar 11, 2022	Supplement 40Labeling · Standard review	Approved	None posted
Mar 11, 2022	Supplement 38Labeling · Standard review	Approved	None posted
Mar 11, 2022	Supplement 37Labeling · Standard review	Approved	None posted
Oct 29, 2008	Supplement 31Labeling	Approved	None posted
Apr 29, 2008	Supplement 28Labeling	Approved	None posted
Nov 28, 2007	Supplement 27Labeling	Approved	None posted
Jul 15, 2007	Supplement 26Labeling	Approved	None posted
Apr 19, 2002	Supplement 19Manufacturing	Approved	None posted
Mar 25, 2002	Supplement 20Manufacturing	Approved	None posted
Oct 22, 2001	Supplement 18Manufacturing	Approved	None posted
Oct 5, 2001	Supplement 17Manufacturing	Approved	None posted
Oct 5, 2001	Supplement 16Manufacturing	Approved	None posted
Nov 13, 2000	Supplement 15Manufacturing	Approved	None posted
Nov 13, 2000	Supplement 13Manufacturing	Approved	None posted
Nov 13, 2000	Supplement 12Manufacturing	Approved	None posted
Nov 13, 2000	Supplement 11Manufacturing	Approved	None posted
Aug 17, 2000	Supplement 8Labeling	Approved	None posted
Aug 17, 2000	Supplement 7Manufacturing	Approved	None posted
May 5, 1999	Supplement 14Manufacturing	Approved	None posted
Aug 17, 1998	Supplement 10Manufacturing	Approved	None posted
Jul 14, 1998	Supplement 9Manufacturing	Approved	None posted
Oct 3, 1997	Supplement 5Manufacturing	Approved	None posted
May 22, 1997	Supplement 4Manufacturing	Approved	None posted
Dec 1, 1995	Supplement 3Manufacturing	Approved	None posted
Jan 31, 1995	Supplement 2Manufacturing	Approved	None posted
Jan 5, 1995	Supplement 1Manufacturing	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74140
Drugs@FDA: Overview at FDA
Company: Granules India

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