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Dow
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Generated: December 18, 2017

DrugPatentWatch Database Preview

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, Paddock Llc, Upsher-smith Labs, Apotex, Glenmark Generics, Heritage Pharms Inc, and Invagen Pharms, and is included in eight NDAs. It is available from eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the trospium chloride profile page.

Summary for 091688

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Genitourinary Agents

Pharmacology for NDA: 091688

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 69097-912-03 60 TABLET, FILM COATED in 1 BOTTLE (69097-912-03)
TROSPIUM CHLORIDE trospium chloride TABLET;ORAL 091688 ANDA CIPLA USA INC., 69097-912 69097-912-15 1000 TABLET, FILM COATED in 1 BOTTLE (69097-912-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 23, 2016TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Teva
Argus Health
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US Army
US Department of Justice
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