Naproxen

ANDA 212517, held by Sciegen Pharms. Naproxen.

As of Nov 14, 2026, ANDA 212517 (Naproxen), held by Sciegen Pharms, was first approved by FDA on Feb 21, 2020, with 2 approved supplements and 0 published complete response letters.

First approved: Feb 21, 2020
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Feb 21, 2020	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 3 submissions, including labeling and manufacturing supplements


Aug 28, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Mar 2, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Feb 21, 2020	Original application	Approved	None posted

Identifiers

Application: ANDA 212517
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