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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 220012

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NDA 220012 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 220012

Tradename:	COLESTIPOL HYDROCHLORIDE
Applicant:	Pharmobedient
Ingredient:	colestipol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 220012

Anion Exchange Resins
Hypolipidemic Agents
Sequestering Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Sep 15, 2025	TE:	AB	RLD:	No

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