Naproxen Sodium

ANDA 74195, held by Watson Labs. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74195 (Naproxen Sodium), held by Watson Labs, was first approved by FDA on Dec 21, 1993, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Dec 21, 1993	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 8 submissions, including labeling and manufacturing supplements


Jun 8, 2001	Supplement 7Manufacturing	Approved	None posted
Jun 8, 2001	Supplement 8Manufacturing	Approved	None posted
Apr 25, 2001	Supplement 6Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 2Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 3Manufacturing	Approved	None posted
Dec 4, 2000	Supplement 5Manufacturing	Approved	None posted
Jul 13, 1995	Supplement 1Labeling	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74195
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