Naproxen Sodium

ANDA 91353, held by Granules India. Naproxen Sodium.

As of Nov 15, 2026, ANDA 91353 (Naproxen Sodium), held by Granules India, was first approved by FDA on Sep 20, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 20, 2011
Supplements approved: 7
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 ■ backache ■ muscular aches ■ the common cold ■ toothache ■ menstrual cramps ■ 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 8 submissions below

Date	Submission	Status	Documents
Sep 20, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Sep 6, 2022	Supplement 16Labeling · Standard review	Approved	None posted
Sep 6, 2022	Supplement 19Labeling · Standard review	Approved	None posted
Sep 6, 2022	Supplement 21Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 10Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 13Labeling · Standard review	Approved	None posted
Nov 6, 2019	Supplement 15Manufacturing	Approved	None posted
Sep 20, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91353
Drugs@FDA: Overview at FDA
Company: Granules India

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