Trospium Chloride

Treats overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and…. ANDA 91573, held by Padagis US. Trospium Chloride.

As of Nov 15, 2026, ANDA 91573 (Trospium Chloride), held by Padagis US, was first approved by FDA on Nov 17, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 17, 2010
Supplements approved: 3
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 4 submissions below

Date	Submission	Status	Documents
Nov 17, 2010	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Aug 29, 2013	Supplement 3Labeling · Standard review	Approved	None posted
Aug 1, 2011	Supplement 2Manufacturing	Approved	None posted
Mar 31, 2011	Supplement 1Labeling	Approved	None posted
Nov 17, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91573
Drugs@FDA: Overview at FDA
Company: Padagis US LLC

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