Naproxen Sodium

ANDA 212199, held by Sciegen Pharms. Naproxen Sodium.

As of Nov 15, 2026, ANDA 212199 (Naproxen Sodium), held by Sciegen Pharms, was first approved by FDA on Oct 30, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 30, 2019
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Naproxen sodium tablets are non-steroidal anti-inflammatory drugs indicated for: the relief of the signs and symptoms of: rheumatoid arthritis osteoarthritis ankylosing spondylitis polyarticular juvenile idiopathic arthritis

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 30, 2019	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 3 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Jun 25, 2026	Supplement 12Labeling · Standard review	Approved	None posted
Oct 30, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 212199
Drugs@FDA: Overview at FDA
Company: ScieGen 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