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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 215781

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NDA 215781 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 Ltd, and is included in twelve NDAs. It is available from eighteen suppliers. Additional details are available on the TROSPIUM CHLORIDE profile page.

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

Summary for 215781

Tradename:	TROSPIUM CHLORIDE
Applicant:	Chartwell Rx
Ingredient:	trospium chloride
Patents:	0

Pharmacology for NDA: 215781

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 215781

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	215781	ANDA	Zameer Pharmaceuticals LLC	90096-141	90096-141-60	60 TABLET, FILM COATED in 1 BOTTLE (90096-141-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Feb 16, 2022	TE:	AB	RLD:	No

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