Naproxen

ANDA 216908, held by Tp Anda Holdings. Naproxen.

As of Nov 14, 2026, ANDA 216908 (Naproxen), held by Tp Anda Holdings, was first approved by FDA on May 31, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: May 31, 2023
Review: Standard
Supplements approved: 1
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 Naproxen delayed-release 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 2 submissions below

Date	Submission	Status	Documents
May 31, 2023	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 2 submissions, including labeling and manufacturing supplements


Aug 5, 2026	Supplement 2Labeling · Standard review	Approved	None posted
May 31, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 216908
Drugs@FDA: Overview at FDA
Company: TP ANDA Holdings

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