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Last Updated: December 12, 2025

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, Edenbridge Pharms, Pharmobedient, Riconpharma Llc, and Zydus Pharms, and is included in seven NDAs. It is available from seven 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. Nine 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

Pharmacology for NDA: 077277

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 077277

Anion Exchange Resins
Hypolipidemic Agents
Sequestering Agents

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:	RX	Dosage:	GRANULE;ORAL			Strength	5GM/SCOOPFUL
Approval Date:	May 2, 2006	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	5GM/PACKET
Approval Date:	May 2, 2006	TE:	AB	RLD:	No

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