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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Daiichi Sankyo
Farmers Insurance

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022562

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NDA 022562 describes CARBAGLU, which is a drug marketed by Orphan Europe and is included in one NDA. It is available from one supplier. Additional details are available on the CARBAGLU profile page.

The generic ingredient in CARBAGLU is carglumic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the carglumic acid profile page.
Summary for 022562
Applicant:Orphan Europe
Ingredient:carglumic acid
Pharmacology for NDA: 022562
Suppliers and Packaging for NDA: 022562
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBAGLU carglumic acid TABLET;ORAL 022562 NDA Orphan Europe, SARL 52276-312 N 52276-312-05
CARBAGLU carglumic acid TABLET;ORAL 022562 NDA Orphan Europe, SARL 52276-312 N 52276-312-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Mar 18, 2010TE:RLD:Yes

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
Fish and Richardson
Federal Trade Commission
US Army
Chinese Patent Office

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