Details for New Drug Application (NDA): 017563

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NDA 017563 describes FLAVORED COLESTID, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the FLAVORED COLESTID profile page.

The generic ingredient in FLAVORED COLESTID 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 017563

Tradename:	FLAVORED COLESTID
Applicant:	Pfizer
Ingredient:	colestipol hydrochloride
Patents:	0

Pharmacology for NDA: 017563

Mechanism of Action	Bile-acid Binding Activity

Medical Subject Heading (MeSH) Categories for 017563

Anion Exchange Resins
Hypolipidemic Agents
Sequestering Agents

Suppliers and Packaging for NDA: 017563

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563	NDA	Pharmacia & Upjohn Company LLC	0009-0260	0009-0260-02	1 BOTTLE in 1 CARTON (0009-0260-02) / 500 g in 1 BOTTLE
COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563	NDA	Pharmacia & Upjohn Company LLC	0009-0260	0009-0260-04	90 PACKET in 1 CARTON (0009-0260-04) / 5 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	5GM/PACKET
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GRANULE;ORAL			Strength	5GM/SCOOPFUL
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	GRANULE;ORAL			Strength	5GM/SCOOPFUL
Approval Date:	Sep 22, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 017563

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-001	Approved Prior to Jan 1, 1982	3,692,895	⤷ Subscribe
Pfizer	FLAVORED COLESTID	colestipol hydrochloride	GRANULE;ORAL	017563-002	Approved Prior to Jan 1, 1982	3,692,895	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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