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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Farmers Insurance
Federal Trade Commission

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085461

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NDA 085461 describes LIBRIUM, which is a drug marketed by Valeant Pharm Intl and Valeant Pharms Llc and is included in five NDAs. It is available from eight suppliers. Additional details are available on the LIBRIUM profile page.

The generic ingredient in LIBRIUM is chlordiazepoxide hydrochloride. There are eight drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

Summary for 085461

Formulation / Manufacturing:see details

Pharmacology for NDA: 085461


Suppliers and Packaging for NDA: 085461

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085461 ANDA AvKARE, Inc. 42291-210 42291-210-90 90 CAPSULE, GELATIN COATED in 1 BOTTLE (42291-210-90)
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085461 ANDA Solco Healthcare US LLC 43547-251 43547-251-10 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43547-251-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Harvard Business School
US Army

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