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. Fourteen 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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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

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