Last Updated: September 24, 2026

Details for New Drug Application (NDA): 204945

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NDA 204945 describes TROSPIUM CHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Granules, Padagis Us, Upsher Smith Labs, Utopic Pharms, Apotex, Glenmark Pharms Ltd, Heritage Pharms Inc, Invagen Pharms, Macleods Pharms, and Zameer Pharms, and is included in twelve NDAs. It is available from nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for 204945

Tradename:	TROSPIUM CHLORIDE
Applicant:	Heritage Pharms Inc
Ingredient:	trospium chloride
Patents:	0

Pharmacology for NDA: 204945

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 204945

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	204945	ANDA	Major Pharmaceuticals	0904-7059	0904-7059-52	60 TABLET, FILM COATED in 1 BOTTLE (0904-7059-52)
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	204945	ANDA	MAJOR PHARMACEUTICALS	0904-7619	0904-7619-40	500 TABLET, FILM COATED in 1 BOTTLE (0904-7619-40)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Aug 30, 2016	TE:	AB	RLD:	No

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