Naproxen Sodium

ANDA 74367, held by Pharmobedient. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74367 (Naproxen Sodium), held by Pharmobedient, was first approved by FDA on Aug 31, 1994, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 31, 1994
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 31, 1994	Original application	Approved	None posted

Products

2 strengths and forms


Naproxen SodiumEQ 250MG BASE · tablet;oral	Naproxen Sodium	Discontinued
Naproxen SodiumEQ 500MG BASE · tablet;oral	Naproxen Sodium	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Mar 19, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Mar 19, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Mar 19, 2020	Supplement 8Labeling · Standard review	Approved	None posted
May 15, 1998	Supplement 5Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 4, 1997	Supplement 4Manufacturing	Approved	None posted
Apr 18, 1996	Supplement 2Labeling	Approved	None posted
Apr 2, 1996	Supplement 3Manufacturing	Approved	None posted
Jun 23, 1995	Supplement 1Manufacturing	Approved	None posted
Aug 31, 1994	Original application	Approved	None posted

Identifiers

Application: ANDA 74367
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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