Naproxen

ANDA 200429, held by Aurobindo Pharma. Naproxen.

As of Nov 14, 2026, ANDA 200429 (Naproxen), held by Aurobindo Pharma, was first approved by FDA on Nov 8, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Nov 8, 2011
Supplements approved: 7
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 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 8 submissions below

Date	Submission	Status	Documents
Nov 8, 2011	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 8 submissions, including labeling and manufacturing supplements


Mar 13, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Mar 13, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Mar 13, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Oct 3, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Jun 30, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Nov 8, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200429
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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