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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chinese Patent Office
Argus Health
Harvard Business School
Johnson and Johnson

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085475

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NDA 085475 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 085475
Applicant:Valeant Pharm Intl
Ingredient:chlordiazepoxide hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 085475
Suppliers and Packaging for NDA: 085475
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085475 ANDA AvKARE, Inc. 42291-212 N 42291-212-90
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085475 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-699 N 43353-699-53

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Cantor Fitzgerald
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US Army

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