Trospium Chloride

Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 91575, held by Glenmark Pharms Ltd. Trospium Chloride.

As of Nov 15, 2026, ANDA 91575 (Trospium Chloride), held by Glenmark Pharms Ltd, was first approved by FDA on Aug 13, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 13, 2010
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 13, 2010	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Trospium Chloride20MG · tablet;oral	Trospium Chloride	Rx

All 7 submissions, including labeling and manufacturing supplements


Apr 4, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Dec 31, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Jul 31, 2013	Supplement 7Labeling · Standard review	Approved	None posted
Nov 30, 2012	Supplement 5Labeling · Standard review	Approved	None posted
May 31, 2012	Supplement 3Labeling	Approved	None posted
Mar 31, 2011	Supplement 1Labeling	Approved	None posted
Aug 13, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 91575
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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