Naproxen Sodium

ANDA 204872, held by Lnk Intl Inc. Naproxen Sodium.

As of Nov 15, 2026, ANDA 204872 (Naproxen Sodium), held by Lnk Intl Inc, was first approved by FDA on Jan 23, 2017, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 23, 2017
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses temporarily relieves minor aches and pains due to: headache muscular aches the common cold toothache menstrual cramps backache minor pain of arthritis temporarily reduces fever

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 23, 2017	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naproxen Sodium220MG · tablet;oral	Naproxen Sodium	OTC

All 6 submissions, including labeling and manufacturing supplements


Sep 16, 2025	Supplement 1Labeling · Standard review	Approved	None posted
Sep 16, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Sep 16, 2025	Supplement 6Labeling · Standard review	Approved	None posted
Sep 16, 2025	Supplement 8Labeling · Standard review	Approved	None posted
Apr 23, 2025	Supplement 10Manufacturing	Approved	None posted
Jan 23, 2017	Original application	Approved	Letter

Identifiers

Application: ANDA 204872
Drugs@FDA: Overview at FDA
Company: LNK International

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