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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 077277


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NDA 077277 describes COLESTIPOL HYDROCHLORIDE, which is a drug marketed by Impax Labs, Ani Pharms, and Zydus Pharms, and is included in four NDAs. It is available from six suppliers. Additional details are available on the COLESTIPOL HYDROCHLORIDE profile page.

The generic ingredient in COLESTIPOL HYDROCHLORIDE is colestipol hydrochloride. There are two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the colestipol hydrochloride profile page.
Summary for 077277
Tradename:COLESTIPOL HYDROCHLORIDE
Applicant:Impax Labs
Ingredient:colestipol hydrochloride
Patents:0
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 Amneal Pharmaceuticals of New York LLC 0115-5212 0115-5212-18 30 SUSPENSION in 1 CARTON (0115-5212-18)
COLESTIPOL HYDROCHLORIDE colestipol hydrochloride GRANULE;ORAL 077277 ANDA Amneal Pharmaceuticals of New York LLC 0115-5212 0115-5212-29 90 SUSPENSION in 1 CARTON (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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