You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 077510

✉ Email this page to a colleague

« Back to Dashboard

NDA 077510 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 077510

Tradename:	COLESTIPOL HYDROCHLORIDE
Applicant:	Impax Labs
Ingredient:	colestipol hydrochloride
Patents:	0

Pharmacology for NDA: 077510

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 077510

Anion Exchange Resins
Hypolipidemic Agents
Sequestering Agents

Suppliers and Packaging for NDA: 077510

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	077510	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5211	0115-5211-02	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02)
COLESTIPOL HYDROCHLORIDE	colestipol hydrochloride	TABLET;ORAL	077510	ANDA	Amneal Pharmaceuticals of New York LLC	0115-5211	0115-5211-16	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1GM
Approval Date:	Oct 24, 2006	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.