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Generated: May 29, 2017

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 NDA: 077277

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077277

Mechanism of ActionBile-acid Binding Activity

Suppliers and Packaging for NDA: 077277

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
colestipol hydrochloride
GRANULE;ORAL 077277 ANDA Impax Generics 0115-5212 0115-5212-18 30 SUSPENSION in 1 CARTON (0115-5212-18)
colestipol hydrochloride
GRANULE;ORAL 077277 ANDA Impax Generics 0115-5212 0115-5212-29 90 SUSPENSION in 1 CARTON (0115-5212-29)

Summary for product number 001

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

Summary for product number 002

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

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