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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 091688

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NDA 091688 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 091688

Tradename:	TROSPIUM CHLORIDE
Applicant:	Invagen Pharms
Ingredient:	trospium chloride
Patents:	0

Pharmacology for NDA: 091688

Mechanism of Action	Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 091688

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091688	ANDA	CIPLA USA INC.,	69097-912	69097-912-02	30 TABLET, FILM COATED in 1 BOTTLE (69097-912-02)
TROSPIUM CHLORIDE	trospium chloride	TABLET;ORAL	091688	ANDA	CIPLA USA INC.,	69097-912	69097-912-03	60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Aug 23, 2016	TE:	AB	RLD:	No

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