Naproxen Sodium

ANDA 74230, held by Ivax Sub Teva Pharms. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74230 (Naproxen Sodium), held by Ivax Sub Teva Pharms, was first approved by FDA on Mar 14, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 14, 1995
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 14, 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 4 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 3Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 2Manufacturing	Approved	None posted
Dec 2, 1996	Supplement 1Labeling	Approved	None posted
Mar 14, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74230
Drugs@FDA: Overview at FDA
Company: IVAX Pharmaceuticals

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