Oxytrol

Treats overactive bladder. NDA 21351, held by Allergan. Oxybutynin.

As of Nov 14, 2026, NDA 21351 (Oxytrol), held by Allergan, was first approved by FDA on Feb 26, 2003, with 14 approved supplements and 0 published complete response letters.

First approved: Feb 26, 2003
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

OXYTROL is a muscarinic antagonist indicated for the treatment of overactive bladder in men with symptoms of urge urinary incontinence, urgency, and frequency.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Feb 26, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxytrol3.9MG/24HR · film, extended release;transdermal	Oxybutynin	RxReference drug

All 15 submissions, including labeling and manufacturing supplements


May 29, 2024	Supplement 20Labeling · Standard review	Approved	Label Letter
Oct 24, 2017	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 24, 2017	Supplement 17Labeling · Standard review	Approved	Letter Label
Jul 10, 2015	Supplement 16Labeling · Standard review	Approved	Letter Label
Jul 18, 2014	Supplement 15Manufacturing · Standard review	Approved	None posted
May 16, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
Jul 10, 2013	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 3, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
May 29, 2013	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 15, 2013	Supplement 11Manufacturing · Standard review	Approved	None posted
Oct 10, 2012	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 10, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
Jan 31, 2011	Supplement 5Labeling · Standard review	Approved	Letter Label
Jul 5, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Feb 26, 2003	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21351
Drugs@FDA: Overview at FDA
Company: Allergan

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