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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 012249


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NDA 012249 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. Twelve suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.
Summary for 012249
Tradename:LIBRIUM
Applicant:Valeant Pharm Intl
Ingredient:chlordiazepoxide hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 012249

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 012249-002 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharm Intl LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 012249-001 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
Valeant Pharm Intl LIBRIUM chlordiazepoxide hydrochloride CAPSULE;ORAL 012249-003 Approved Prior to Jan 1, 1982 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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