Naproxen

ANDA 78620, held by Zydus Pharms USA. Naproxen.

As of Nov 14, 2026, ANDA 78620 (Naproxen), held by Zydus Pharms USA, was first approved by FDA on Jun 7, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Jun 7, 2007
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
Jun 7, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Naproxen250MG · tablet;oral	Naproxen	Rx
Naproxen375MG · tablet;oral	Naproxen	Rx
Naproxen500MG · tablet;oral	Naproxen	Rx

All 6 submissions, including labeling and manufacturing supplements


Jun 13, 2025	Supplement 5Labeling · Standard review	Approved	None posted
Jun 13, 2025	Supplement 4Labeling · Standard review	Approved	None posted
Jun 13, 2025	Supplement 3Labeling · Standard review	Approved	None posted
Jun 13, 2025	Supplement 2Labeling · Standard review	Approved	None posted
Aug 22, 2008	Supplement 1Labeling	Approved	None posted
Jun 7, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78620
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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