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Cerilliant
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Generated: December 18, 2017

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 five 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. Five suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.

Summary for 012750

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0187-4100-10 100 CAPSULE in 1 BOTTLE (0187-4100-10)
LIBRAX chlordiazepoxide hydrochloride; clidinium bromide CAPSULE;ORAL 012750 NDA AUTHORIZED GENERIC Cameron Pharmaceuticals, LLC 42494-409 42494-409-01 100 CAPSULE in 1 BOTTLE (42494-409-01)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 012750

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant PharmsLIBRAXchlordiazepoxide hydrochloride; clidinium bromideCAPSULE;ORAL012750-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fuji
Accenture
Daiichi Sankyo
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