Detrol La

NDA 21228, held by Upjohn. Tolterodine Tartrate.

As of Nov 14, 2026, NDA 21228 (Detrol La), held by Upjohn, was first approved by FDA on Dec 22, 2000, with 15 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2000
Review: Standard
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Oct 20, 2005	Supplement 7Efficacy (new indication or use)	Approved	Letter Label
Apr 14, 2004	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Dec 22, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Statistical Review

Products

2 strengths and forms


Detrol La2MG · capsule, extended release;oral	Tolterodine Tartrate	DiscontinuedReference drug
Detrol La4MG · capsule, extended release;oral	Tolterodine Tartrate	DiscontinuedReference drug

All 16 submissions, including labeling and manufacturing supplements


Jul 13, 2018	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 28, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 1, 2012	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 20, 2011	Supplement 16Labeling · Standard review	Approved	Letter Label
Jan 5, 2010	Supplement 15Labeling · Standard review	Approved	Label Letter
Sep 11, 2008	Supplement 12Labeling · Standard review	Approved	Letter
Mar 16, 2007	Supplement 10Labeling · Standard review	Approved	Label Letter
Oct 20, 2005	Supplement 7Efficacy (new indication or use)	Approved	Letter Label
Jul 14, 2005	Supplement 8Labeling · Standard review	Approved	Letter Label
Apr 14, 2004	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Review Label Letter
Jan 15, 2004	Supplement 5Labeling · Standard review	Approved	Letter
Jul 21, 2003	Supplement 4Labeling · Standard review	Approved	Letter
Dec 17, 2001	Supplement 3Manufacturing · Standard review	Approved	Review
Sep 21, 2001	Supplement 2Labeling · Standard review	Approved	Review
Apr 27, 2001	Supplement 1Labeling · Standard review	Approved	Review Label
Dec 22, 2000	Original applicationNew dosage form · Standard review	Approved	Review Letter Label Pediatric Statistical Review

Identifiers

Application: NDA 21228
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