Last Updated: November 13, 2026

Details for New Drug Application (NDA): 091635

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NDA 091635 describes TROSPIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, and Macleods Pharms, and is included in twelve NDAs. It is available from twenty suppliers. Additional details are available on the TROSPIUM CHLORIDE profile page.

The generic ingredient in TROSPIUM CHLORIDE is trospium chloride. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for 091635

Tradename:	TROSPIUM CHLORIDE
Applicant:	Upsher Smith Labs
Ingredient:	trospium chloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Apr 29, 2015	TE:		RLD:	No

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