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Generated: November 19, 2018

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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. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
Summary for 085461
Tradename:LIBRIUM
Applicant:Valeant Pharm Intl
Ingredient:chlordiazepoxide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 085461
Ingredient-typeBenzodiazepines
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)

Profile 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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