Trospium Chloride

ANDA 91513, held by Apotex. Trospium Chloride.

As of Nov 15, 2026, ANDA 91513 (Trospium Chloride), held by Apotex, was first approved by FDA on Dec 6, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 6, 2011
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Dec 6, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jan 30, 2013	Supplement 2Labeling · Standard review	Approved	None posted
Dec 6, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91513
Drugs@FDA: Overview at FDA
Company: Apotex

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