Naproxen Sodium

ANDA 90545, held by Pharmazone. Naproxen Sodium.

As of Nov 15, 2026, ANDA 90545 (Naproxen Sodium), held by Pharmazone, was first approved by FDA on Mar 16, 2011, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2011
Supplements approved: 3
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: minor pain of arthritis muscular aches backache menstrual cramps headache toothache the common cold temporarily reduces fever

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 16, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Jul 21, 2023	Supplement 1Labeling · Standard review	Approved	None posted
Jul 21, 2023	Supplement 2Labeling · Standard review	Approved	None posted
Jul 21, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Mar 16, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90545
Drugs@FDA: Overview at FDA
Company: Pharmazone

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