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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
US Department of Justice
Farmers Insurance
Fish and Richardson

Generated: July 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091289

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NDA 091289 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: 091289

Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 091289

Suppliers and Packaging for NDA: 091289

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Oct 12, 2012TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Queensland Health
Harvard Business School
Fish and Richardson
Cantor Fitzgerald
Express Scripts
US Army

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