Naproxen Sodium

ANDA 74635, held by Contract Pharmacal. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74635 (Naproxen Sodium), held by Contract Pharmacal, was first approved by FDA on Jan 13, 1997, with 14 approved supplements and 0 published complete response letters.

First approved: Jan 13, 1997
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Jan 13, 1997	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naproxen Sodium220MG · tablet;oral	Naproxen Sodium	OTC

All 15 submissions, including labeling and manufacturing supplements


Mar 13, 2006	Supplement 17Labeling	Approved	None posted
Sep 4, 2002	Supplement 15Manufacturing	Approved	None posted
Apr 29, 2002	Supplement 14Manufacturing	Approved	None posted
Apr 29, 2002	Supplement 13Manufacturing	Approved	None posted
Sep 21, 2000	Supplement 12Manufacturing	Approved	None posted
Aug 2, 2000	Supplement 10Manufacturing	Approved	None posted
Mar 3, 2000	Supplement 7Manufacturing	Approved	None posted
Mar 3, 2000	Supplement 6Manufacturing	Approved	None posted
Aug 24, 1999	Supplement 8Labeling	Approved	None posted
Apr 14, 1999	Supplement 1Manufacturing	Approved	None posted
Feb 11, 1999	Supplement 5Manufacturing	Approved	None posted
Feb 11, 1999	Supplement 4Manufacturing	Approved	None posted
Dec 7, 1998	Supplement 2Manufacturing	Approved	None posted
Apr 28, 1998	Supplement 3Manufacturing	Approved	None posted
Jan 13, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74635
Drugs@FDA: Overview at FDA
Company: Contract Pharmacal Corporation

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