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Generated: July 28, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201291

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NDA 201291 describes TROSPIUM CHLORIDE, which is a drug marketed by Apotex, Upsher-smith Labs, Heritage Pharms Inc, Paddock Llc, Glenmark Generics, Invagen Pharms, and Actavis Labs Fl Inc, and is included in eight NDAs. It is available from ten 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. Ten suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for NDA: 201291

Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 201291

Suppliers and Packaging for NDA: 201291

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
trospium chloride
CAPSULE, EXTENDED RELEASE;ORAL 201291 ANDA Paddock Laboratories, LLC 0574-0118 0574-0118-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0574-0118-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:May 24, 2013TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

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