Naproxen Sodium

ANDA 74455, held by Watson Labs. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74455 (Naproxen Sodium), held by Watson Labs, was first approved by FDA on May 31, 1995, with 5 approved supplements and 0 published complete response letters.

First approved: May 31, 1995
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
May 31, 1995	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 6 submissions, including labeling and manufacturing supplements


Mar 2, 2006	Supplement 6Labeling	Approved	None posted
Oct 29, 1997	Supplement 4Manufacturing	Approved	None posted
Oct 29, 1997	Supplement 3Manufacturing	Approved	None posted
Oct 29, 1997	Supplement 2Manufacturing	Approved	None posted
Oct 29, 1997	Supplement 1Manufacturing	Approved	None posted
May 31, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74455
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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