Details for New Drug Application (NDA): 012750

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NDA 012750 describes LIBRAX, which is a drug marketed by Bausch and is included in one NDA. It is available from one supplier. Additional details are available on the LIBRAX profile page.

The generic ingredient in LIBRAX is chlordiazepoxide hydrochloride; clidinium bromide. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.

Summary for 012750

Tradename:	LIBRAX
Applicant:	Bausch
Ingredient:	chlordiazepoxide hydrochloride; clidinium bromide
Patents:	0

Pharmacology for NDA: 012750

Mechanism of Action	Cholinergic Antagonists
Physiological Effect	Decreased Parasympathetic Acetylcholine Activity Digestive/GI System Activity Alteration GI Motility Alteration

Suppliers and Packaging for NDA: 012750

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIBRAX	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	012750	NDA	Bausch Health US, LLC	0187-4100	0187-4100-10	100 CAPSULE in 1 BOTTLE (0187-4100-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG;2.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 012750

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	LIBRAX	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	012750-001	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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