Naproxen Sodium

ANDA 74480, held by Hikma. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74480 (Naproxen Sodium), held by Hikma, was first approved by FDA on May 14, 1996, with 20 approved supplements and 0 published complete response letters.

First approved: May 14, 1996
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
May 14, 1996	Original application	Approved	None posted

Products

2 strengths and forms


Naproxen SodiumEQ 500MG BASE · tablet;oral	Naproxen Sodium	Discontinued
Naproxen SodiumEQ 250MG BASE · tablet;oral	Naproxen Sodium	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Sep 8, 2008	Supplement 27Labeling	Approved	None posted
May 8, 2008	Supplement 24Labeling	Approved	None posted
Oct 16, 2007	Supplement 23Labeling	Approved	None posted
Oct 5, 2006	Supplement 22Labeling	Approved	None posted
Jun 7, 2006	Supplement 21Labeling	Approved	None posted
Jun 9, 2005	Supplement 17Labeling	Approved	None posted
Apr 9, 1999	Supplement 14Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 13Manufacturing	Approved	None posted
Mar 6, 1998	Supplement 4Labeling	Approved	None posted
Mar 6, 1998	Supplement 3Manufacturing	Approved	None posted
Mar 6, 1998	Supplement 2Manufacturing	Approved	None posted
Mar 6, 1998	Supplement 1Manufacturing	Approved	None posted
Feb 18, 1998	Supplement 12Manufacturing	Approved	None posted
Feb 18, 1998	Supplement 11Manufacturing	Approved	None posted
Feb 18, 1998	Supplement 10Manufacturing	Approved	None posted
Feb 18, 1998	Supplement 9Manufacturing	Approved	None posted
Feb 18, 1998	Supplement 8Manufacturing	Approved	None posted
Feb 18, 1998	Supplement 7Labeling	Approved	None posted
Feb 18, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 14, 1997	Supplement 5Manufacturing	Approved	None posted
May 14, 1996	Original application	Approved	None posted

Identifiers

Application: ANDA 74480
Drugs@FDA: Overview at FDA
Company: Hikma

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