Naprelan

Relieves mild to moderate pain. NDA 20353, held by Twi Pharms. Naproxen Sodium.

As of Nov 14, 2026, NDA 20353 (Naprelan), held by Twi Pharms, was first approved by FDA on Jan 5, 1996, with 24 approved supplements and 0 published complete response letters.

First approved: Jan 5, 1996
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Naproxen Sodium Controlled-Release Tablets are indicated for the treatment of: rheumatoid arthritis (RA) osteoarthritis (OA) ankylosing spondylitis (AS) tendinitis, bursitis acute gout primary dysmenorrhea (PD) the relief of mild to moderate pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jan 5, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Products

3 strengths and forms


NaprelanEQ 375MG BASE · tablet, extended release;oral	Naproxen Sodium	RxReference drug
NaprelanEQ 500MG BASE · tablet, extended release;oral	Naproxen Sodium	RxReference drug
NaprelanEQ 750MG BASE · tablet, extended release;oral	Naproxen Sodium	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Nov 21, 2024	Supplement 41Labeling · Standard review	Approved	Letter Label Medication Guide
Apr 28, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Jul 22, 2019	Supplement 36Labeling · Standard review	Approved	Letter Label
Sep 6, 2017	Supplement 34Manufacturing	Approved	Label
May 9, 2016	Supplement 32Labeling · Standard review	Approved	Letter Label
May 9, 2016	Supplement 31Labeling · Standard review	Approved	Letter Label
Sep 12, 2014	Supplement 30Manufacturing · Standard review	Approved	None posted
Nov 8, 2011	Supplement 28Labeling · Standard review	Approved	Letter Label
Jul 8, 2009	Supplement 23Manufacturing	Approved	Label Letter
May 29, 2007	Supplement 19Labeling · Standard review	Approved	Letter
Jan 18, 2006	Supplement 16Labeling · Standard review	Approved	Letter Label
Apr 15, 2002	Supplement 14Manufacturing · Standard review	Approved	None posted
Feb 4, 2002	Supplement 8Labeling · Standard review	Approved	None posted
Oct 2, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 4, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 15, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 15, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 2, 1999	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 20, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 23, 1997	Supplement 6Manufacturing · Standard review	Approved	None posted
May 12, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 31, 1997	Supplement 4Manufacturing · Standard review	Approved	None posted
Jan 31, 1997	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 28, 1996	Supplement 1Labeling · Standard review	Approved	Review
Jan 5, 1996	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 20353
Drugs@FDA: Overview at FDA
Company: TWi 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