Detrol

Treats overactive bladder with symptoms of urge urinary incontinence, urgency, and…. NDA 20771, held by Upjohn. Tolterodine Tartrate.

As of Nov 13, 2026, NDA 20771 (Detrol), held by Upjohn, was first approved by FDA on Mar 25, 1998, with 16 approved supplements and 0 published complete response letters.

First approved: Mar 25, 1998
Review: Standard
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE DETROL Tablets are indicated for the treatment of overactive bladder 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 17 submissions below


Apr 6, 2001	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Mar 25, 1998	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Products

2 strengths and forms


Detrol1MG · tablet;oral	Tolterodine Tartrate	RxReference drug
Detrol2MG · tablet;oral	Tolterodine Tartrate	RxReference drug

All 17 submissions, including labeling and manufacturing supplements


Jul 28, 2014	Supplement 29Manufacturing · Standard review	Approved	None posted
Aug 1, 2012	Supplement 28Labeling · Standard review	Approved	Letter Label
Sep 20, 2011	Supplement 24Labeling · Standard review	Approved	Letter Label
Apr 8, 2009	Supplement 22Labeling · Standard review	Approved	Letter Label
Sep 11, 2008	Supplement 19Labeling · Standard review	Approved	Letter Label
Mar 16, 2007	Supplement 17Labeling · Standard review	Approved	Letter
Mar 24, 2006	Supplement 14Labeling · Standard review	Approved	Letter
Oct 17, 2005	Supplement 13Labeling · Standard review	Approved	Letter Label
Jan 5, 2004	Supplement 11Labeling · Standard review	Approved	Review Letter
Jul 21, 2003	Supplement 10Labeling · Standard review	Approved	Letter
Jul 20, 2001	Supplement 9Manufacturing · Standard review	Approved	Review
Apr 6, 2001	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 9, 2000	Supplement 5Manufacturing · Standard review	Approved	None posted
Oct 24, 2000	Supplement 6Labeling · Standard review	Approved	None posted
May 26, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
Aug 31, 1998	Supplement 1Manufacturing · Standard review	Approved	None posted
Mar 25, 1998	Original applicationNew molecular entity · Standard review	Approved	Label Letter Review

Identifiers

Application: NDA 20771
Drugs@FDA: Overview at FDA
Company: Upjohn

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