Last Updated: November 9, 2026

Details for New Drug Application (NDA): 091573

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NDA 091573 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 091573

Tradename:	TROSPIUM CHLORIDE
Applicant:	Padagis Us
Ingredient:	trospium chloride
Patents:	0

Pharmacology for NDA: 091573

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 091573

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091573	ANDA	Padagis US LLC	0574-0145	0574-0145-60	60 TABLET, FILM COATED in 1 BOTTLE (0574-0145-60)
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091573	ANDA	Bryant Ranch Prepack	63629-8457	63629-8457-1	60 TABLET, FILM COATED in 1 BOTTLE (63629-8457-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Nov 17, 2010	TE:	AB	RLD:	No

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