Naproxen Sodium

ANDA 202807, held by Catalent. Naproxen Sodium.

As of Nov 15, 2026, ANDA 202807 (Naproxen Sodium), held by Catalent, was first approved by FDA on Jan 4, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 4, 2019
Supplements approved: 4
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 minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 4, 2019	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naproxen SodiumEQ 200MG BASE · capsule;oral	Naproxen Sodium	OTC

All 5 submissions, including labeling and manufacturing supplements


Sep 19, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Sep 19, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Apr 9, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Apr 9, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jan 4, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 202807
Drugs@FDA: Overview at FDA
Company: Catalent

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