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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 213185

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NDA 213185 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 213185

Tradename:	TROSPIUM CHLORIDE
Applicant:	Granules
Ingredient:	trospium chloride
Patents:	0

Pharmacology for NDA: 213185

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 213185

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	213185	ANDA	Bluepoint Laboratories	68001-427	68001-427-04	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-427-04)
TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	213185	ANDA	Granules Pharmaceuticals Inc.	70010-027	70010-027-03	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-027-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Apr 23, 2020	TE:	AB	RLD:	No

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