Naproxen Sodium

ANDA 74257, held by Roxane. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74257 (Naproxen Sodium), held by Roxane, was first approved by FDA on Dec 21, 1993, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 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 3 submissions, including labeling and manufacturing supplements


Aug 28, 1996	Supplement 2Manufacturing	Approved	None posted
May 17, 1996	Supplement 1Labeling	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74257
Drugs@FDA: Overview at FDA
Company: Roxane 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