Naproxen

ANDA 91305, held by Invagen Pharms. Naproxen.

As of Nov 14, 2026, ANDA 91305 (Naproxen), held by Invagen Pharms, was first approved by FDA on Aug 24, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 24, 2011
Supplements approved: 4
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 5 submissions below

Date	Submission	Status	Documents
Aug 24, 2011	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 5 submissions, including labeling and manufacturing supplements


Oct 25, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Oct 25, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Aug 3, 2016	Supplement 5Labeling · Standard review	Approved	None posted
Aug 3, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Aug 24, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91305
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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