Oxybutynin Chloride

Relieves symptoms of bladder instability associated with voiding. ANDA 71655, held by Teva Pharms USA. Oxybutynin Chloride.

As of Nov 15, 2026, ANDA 71655 (Oxybutynin Chloride), held by Teva Pharms USA, was first approved by FDA on Nov 14, 1988, with 16 approved supplements and 0 published complete response letters.

First approved: Nov 14, 1988
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Oxybutynin Chloride Tablets USP are indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Nov 14, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oxybutynin Chloride5MG · tablet;oral	Oxybutynin Chloride	Rx

All 17 submissions, including labeling and manufacturing supplements


Jun 13, 2012	Supplement 25Labeling · Standard review	Approved	None posted
Oct 28, 2011	Supplement 24Labeling	Approved	None posted
Mar 9, 2010	Supplement 23Labeling	Approved	None posted
Feb 19, 2008	Supplement 15Labeling	Approved	None posted
May 29, 2001	Supplement 12Manufacturing	Approved	None posted
May 24, 2001	Supplement 10Manufacturing	Approved	None posted
May 24, 2001	Supplement 9Manufacturing	Approved	None posted
May 24, 2001	Supplement 8Manufacturing	Approved	None posted
Mar 20, 2001	Supplement 11Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 7Manufacturing	Approved	None posted
Oct 31, 1996	Supplement 6Manufacturing	Approved	None posted
May 11, 1994	Supplement 5Manufacturing	Approved	None posted
Feb 15, 1994	Supplement 1Manufacturing	Approved	None posted
Jun 4, 1992	Supplement 4Labeling	Approved	None posted
Feb 27, 1992	Supplement 3Labeling	Approved	None posted
Feb 21, 1990	Supplement 2Labeling	Approved	None posted
Nov 14, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 71655
Drugs@FDA: Overview at FDA
Company: Teva 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