Naproxen Sodium

ANDA 74789, held by Contract Pharmacal. Naproxen Sodium.

As of Nov 15, 2026, ANDA 74789 (Naproxen Sodium), held by Contract Pharmacal, was first approved by FDA on Feb 27, 1997, with 4 approved supplements and 0 published complete response letters.

First approved: Feb 27, 1997
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Feb 27, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Mar 13, 2006	Supplement 6Labeling	Approved	None posted
Mar 12, 2001	Supplement 2Manufacturing	Approved	None posted
Dec 13, 1999	Supplement 3Labeling	Approved	None posted
Aug 11, 1997	Supplement 1Manufacturing	Approved	None posted
Feb 27, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74789
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