Naproxen

ANDA 218497, held by Novitium Pharma. Naproxen.

As of Nov 14, 2026, ANDA 218497 (Naproxen), held by Novitium Pharma, was first approved by FDA on Jun 12, 2024, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 12, 2024
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Naproxen delayed-release tablets are 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
Jun 12, 2024	Original application	Approved	None posted

Products

2 strengths and forms


Naproxen375MG · tablet, delayed release;oral	Naproxen	Rx
Naproxen500MG · tablet, delayed release;oral	Naproxen	Rx

All 3 submissions, including labeling and manufacturing supplements


Jun 25, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Oct 25, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Jun 12, 2024	Original application	Approved	None posted

Identifiers

Application: ANDA 218497
Drugs@FDA: Overview at FDA
Company: Novitium Pharma

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