Naproxen

ANDA 91416, held by Pharmazone. Naproxen.

As of Nov 14, 2026, ANDA 91416 (Naproxen), held by Pharmazone, was first approved by FDA on Feb 14, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Feb 14, 2011
Supplements approved: 1
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 2 submissions below

Date	Submission	Status	Documents
Feb 14, 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 2 submissions, including labeling and manufacturing supplements


Jun 29, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Feb 14, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91416
Drugs@FDA: Overview at FDA
Company: Pharmazone

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