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Last Updated: July 14, 2020

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Details for New Drug Application (NDA): 085472

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NDA 085472 describes LIBRIUM, which is a drug marketed by Valeant Pharm Intl and Bausch and is included in five NDAs. It is available from five suppliers. Additional details are available on the LIBRIUM profile page.

The generic ingredient in LIBRIUM is chlordiazepoxide hydrochloride. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
Summary for 085472
Applicant:Valeant Pharm Intl
Ingredient:chlordiazepoxide hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 085472
Suppliers and Packaging for NDA: 085472
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085472 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-969 43353-969-53 60 CAPSULE, GELATIN COATED in 1 BOTTLE (43353-969-53)
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085472 ANDA Solco Healthcare US LLC 43547-252 43547-252-10 100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (43547-252-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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