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Details for New Drug Application (NDA): 012249

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NDA 012249 describes LIBRIUM, which is a drug marketed by Valeant Pharms Llc and Valeant Pharm Intl and is included in five NDAs. It is available from six 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. Sixteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride profile page.

Summary for NDA: 012249

Tradename:
LIBRIUM
Applicant:
Valeant Pharm Intl
Ingredient:
chlordiazepoxide hydrochloride
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

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

Expired Orange Book Patents for NDA: 012249

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl
LIBRIUM
chlordiazepoxide hydrochloride
CAPSULE;ORAL012249-002Approved Prior to Jan 1, 19824,316,897► subscribe
Valeant Pharm Intl
LIBRIUM
chlordiazepoxide hydrochloride
CAPSULE;ORAL012249-003Approved Prior to Jan 1, 19824,316,897► subscribe
Valeant Pharm Intl
LIBRIUM
chlordiazepoxide hydrochloride
CAPSULE;ORAL012249-001Approved Prior to Jan 1, 19824,316,897► subscribe
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