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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Johnson and Johnson
US Department of Justice
Federal Trade Commission

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077277

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NDA 077277 describes COLESTIPOL HYDROCHLORIDE, which is a drug marketed by Impax Labs and is included in two NDAs. It is available from one supplier. Additional details are available on the COLESTIPOL HYDROCHLORIDE profile page.

The generic ingredient in COLESTIPOL HYDROCHLORIDE is colestipol hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
Summary for 077277
Applicant:Impax Labs
Ingredient:colestipol hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077277
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 077277
Suppliers and Packaging for NDA: 077277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLESTIPOL HYDROCHLORIDE colestipol hydrochloride GRANULE;ORAL 077277 ANDA Impax Generics 0115-5212 N 0115-5212-18
COLESTIPOL HYDROCHLORIDE colestipol hydrochloride GRANULE;ORAL 077277 ANDA Impax Generics 0115-5212 N 0115-5212-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength5GM/SCOOPFUL
Approval Date:May 2, 2006TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength5GM/PACKET
Approval Date:May 2, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Queensland Health
Daiichi Sankyo
Harvard Business School
US Department of Justice

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