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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
US Department of Justice

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 012750

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

The generic ingredient in LIBRAX is chlordiazepoxide hydrochloride; clidinium bromide. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.
Summary for 012750
Applicant:Valeant Pharms
Ingredient:chlordiazepoxide hydrochloride; clidinium bromide
Formulation / Manufacturing:see details
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 Valeant Pharmaceuticals International 0187-4100 N 0187-4100-10
LIBRAX chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 012750 NDA AUTHORIZED GENERIC Cameron Pharmaceuticals, LLC 42494-409 N 42494-409-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG;2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim

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