Naproxen Sodium

ANDA 78486, held by Dr Reddys Labs Ltd. Naproxen Sodium.

As of Nov 15, 2026, ANDA 78486 (Naproxen Sodium), held by Dr Reddys Labs Ltd, was first approved by FDA on Jul 26, 2007, with 8 approved supplements and 0 published complete response letters.

First approved: Jul 26, 2007
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis 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 9 submissions below

Date	Submission	Status	Documents
Jul 26, 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 9 submissions, including labeling and manufacturing supplements


Jun 10, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Jun 10, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Jun 10, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 2Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 4Labeling · Standard review	Approved	None posted
Dec 10, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Oct 14, 2008	Supplement 1Labeling	Approved	None posted
Jul 26, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78486
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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