Naproxen Sodium

ANDA 78314, held by Glenmark Pharms Ltd. Naproxen Sodium.

As of Nov 15, 2026, ANDA 78314 (Naproxen Sodium), held by Glenmark Pharms Ltd, was first approved by FDA on Apr 27, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Apr 27, 2007
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Naproxen tablets and naproxen sodium tablets are indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets and naproxen sodium 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 6 submissions below

Date	Submission	Status	Documents
Apr 27, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Naproxen SodiumEQ 250MG BASE · tablet;oral	Naproxen Sodium	Rx
Naproxen SodiumEQ 500MG BASE · tablet;oral	Naproxen Sodium	Rx

All 6 submissions, including labeling and manufacturing supplements


Jul 28, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Mar 2, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Sep 8, 2008	Supplement 2Labeling	Approved	None posted
Apr 27, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78314
Drugs@FDA: Overview at FDA
Company: Glenmark 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