Details for New Drug Application (NDA): 091289

NDA 091289 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 nineteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for 091289

Tradename:	TROSPIUM CHLORIDE
Applicant:	Actavis Labs Fl Inc
Ingredient:	trospium chloride
Patents:	0

Pharmacology for NDA: 091289

Mechanism of Action

Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 091289

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	091289	ANDA	Actavis Pharma, Inc.	0591-3636	0591-3636-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-05)
TROSPIUM CHLORIDE	trospium chloride	CAPSULE, EXTENDED RELEASE;ORAL	091289	ANDA	Actavis Pharma, Inc.	0591-3636	0591-3636-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0591-3636-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Oct 12, 2012	TE:	AB	RLD:	No

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