Naproxen

ANDA 75061, held by Fosun Pharma. Naproxen.

As of Nov 14, 2026, ANDA 75061 (Naproxen), held by Fosun Pharma, was first approved by FDA on Feb 18, 1998, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 18, 1998
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Feb 18, 1998	Original application	Approved	Review

Products

2 strengths and forms


Naproxen375MG · tablet, delayed release;oral	Naproxen	Discontinued
Naproxen500MG · tablet, delayed release;oral	Naproxen	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jul 20, 2015	Supplement 27Labeling · Standard review	Approved	None posted
Oct 29, 2008	Supplement 23Labeling	Approved	None posted
Apr 29, 2008	Supplement 20Labeling	Approved	None posted
Nov 28, 2007	Supplement 19Labeling	Approved	None posted
Jul 15, 2007	Supplement 16Labeling	Approved	None posted
Dec 10, 2003	Supplement 12Labeling	Approved	None posted
May 10, 2002	Supplement 5Manufacturing	Approved	None posted
May 10, 2002	Supplement 4Manufacturing	Approved	None posted
Oct 3, 2001	Supplement 3Manufacturing	Approved	None posted
Oct 3, 2001	Supplement 2Manufacturing	Approved	None posted
Aug 2, 2000	Supplement 1Manufacturing	Approved	None posted
Feb 18, 1998	Original application	Approved	Review

Identifiers

Application: ANDA 75061
Drugs@FDA: Overview at FDA
Company: Fosun Pharma

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