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Last Updated: November 13, 2024

Details for New Drug Application (NDA): 085472


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NDA 085472 describes LIBRIUM, which is a drug marketed by Bausch and Valeant Pharm Intl and is included in five NDAs. It is available from three 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. Fourteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
Summary for 085472
Tradename:LIBRIUM
Applicant:Valeant Pharm Intl
Ingredient:chlordiazepoxide hydrochloride
Patents:0
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 Epic Pharma LLC 42806-562 42806-562-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-562-01)
LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 085472 ANDA Epic Pharma, LLC 42806-565 42806-565-01 100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-565-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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