Naproxen

ANDA 74111, held by Ivax Sub Teva Pharms. Naproxen.

As of Nov 14, 2026, ANDA 74111 (Naproxen), held by Ivax Sub Teva Pharms, was first approved by FDA on Feb 28, 1995, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 28, 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
Feb 28, 1995	Original application	Approved	None posted

Products

3 strengths and forms


Naproxen250MG · tablet;oral	Naproxen	Discontinued
Naproxen375MG · tablet;oral	Naproxen	Discontinued
Naproxen500MG · tablet;oral	Naproxen	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
Feb 28, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74111
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