Naproxen

ANDA 74105, held by Dava Pharms Inc. Naproxen.

As of Nov 14, 2026, ANDA 74105 (Naproxen), held by Dava Pharms Inc, was first approved by FDA on Dec 21, 1993, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 21, 1993
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 21, 1993	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 6 submissions, including labeling and manufacturing supplements


Oct 30, 1997	Supplement 5Manufacturing	Approved	None posted
Sep 22, 1997	Supplement 4Manufacturing	Approved	None posted
Jul 26, 1996	Supplement 3Manufacturing	Approved	None posted
Feb 29, 1996	Supplement 2Labeling	Approved	None posted
May 22, 1995	Supplement 1Manufacturing	Approved	None posted
Dec 21, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 74105
Drugs@FDA: Overview at FDA
Company: DAVA 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