Ec-Naprosyn

NDA 20067, held by Atnahs Pharma US. Naproxen.

As of Nov 13, 2026, NDA 20067 (Ec-Naprosyn), held by Atnahs Pharma US, was first approved by FDA on Oct 14, 1994, with 20 approved supplements and 0 published complete response letters.

First approved: Oct 14, 1994
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

NAPROXEN Tablets, Naproxen Delayed-Release Tablets, and NAPROXEN SODIUM are indicated for: the relief of the signs and symptoms of:

rheumatoid arthritis
osteoarthritis
ankylosing spondylitis
Polyarticular Juvenile Idiopathic Arthritis NAPROXEN Tablets and NAPROXEN SODIUM are also indicated for: the relief of signs and symptoms of:
tendonitis
bursitis
acute gout the management of:
pain
primary dysmenorrhea

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Oct 14, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Ec-Naprosyn375MG · tablet, delayed release;oral	Naproxen	RxReference drug
Ec-Naprosyn500MG · tablet, delayed release;oral	Naproxen	RxReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 21, 2024	Supplement 26Labeling · Standard review	Approved	Letter Label Medication Guide
May 13, 2024	Supplement 25Labeling · Standard review	Approved	Letter Label
Apr 28, 2021	Supplement 24Labeling · Standard review	Approved	Label Letter
Jul 22, 2019	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 10, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 22, 2013	Supplement 18Labeling · Standard review	Approved	Letter Label
Jul 25, 2008	Supplement 17Labeling · Standard review	Approved	Letter Label
Sep 20, 2007	Supplement 14Labeling · Standard review	Approved	Label Letter
Apr 19, 2007	Supplement 13Labeling · Standard review	Approved	Letter
Mar 10, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 24, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
Nov 10, 2004	Supplement 6Labeling · Standard review	Approved	Letter Label
Nov 10, 2004	Supplement 4Labeling · Standard review	Approved	Letter Label
May 19, 2003	Supplement 5Labeling · Standard review	Approved	Letter
Feb 22, 2002	Supplement 9Manufacturing · Standard review	Approved	None posted
Nov 9, 2001	Supplement 8Manufacturing · Standard review	Approved	None posted
Jul 9, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 28, 1996	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 6, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 14, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20067
Drugs@FDA: Overview at FDA
Company: Atnahs Pharma US

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