Sanctura

NDA 21595, held by Allergan. Trospium Chloride.

As of Nov 14, 2026, NDA 21595 (Sanctura), held by Allergan, was first approved by FDA on May 28, 2004, with 8 approved supplements and 0 published complete response letters.

First approved: May 28, 2004
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
May 28, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sanctura20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Trospium Chloride	DiscontinuedReference drug

All 9 submissions, including labeling and manufacturing supplements


Jul 23, 2012	Supplement 9Labeling · Standard review	Approved	Letter Label
Jul 23, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 14, 2011	Supplement 6Labeling · Standard review	Approved	Label Letter
Jan 31, 2011	Supplement 7Labeling · Standard review	Approved	Label Letter
Jun 1, 2009	Supplement 5Labeling · Standard review	Approved	Label
Dec 7, 2006	Supplement 3Labeling · Standard review	Approved	Letter
Sep 5, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Mar 11, 2005	Supplement 1Labeling · Standard review	Approved	Label Letter
May 28, 2004	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21595
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