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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 217667

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NDA 217667 describes COLESTIPOL HYDROCHLORIDE, which is a drug marketed by Impax Labs, Ani Pharms, Edenbridge Pharms, and Zydus Pharms, and is included in five 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 217667

Tradename:	COLESTIPOL HYDROCHLORIDE
Applicant:	Edenbridge Pharms
Ingredient:	colestipol hydrochloride
Patents:	0

Pharmacology for NDA: 217667

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 217667

Anion Exchange Resins
Hypolipidemic Agents
Sequestering Agents

Suppliers and Packaging for NDA: 217667

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	217667	ANDA	Edenbridge Pharmaceuticals LLC.	42799-115	42799-115-01	120 TABLET in 1 BOTTLE (42799-115-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Aug 16, 2024	TE:	AB	RLD:	No

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