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Last Updated: April 17, 2024

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. Seven 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 017563
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 017563
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 0009-0260-01 30 PACKET in 1 CARTON (0009-0260-01) / 5 g in 1 PACKET
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength5GM/PACKET
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength5GM/SCOOPFUL
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:GRANULE;ORALStrength5GM/SCOOPFUL
Approval Date:Sep 22, 1995TE:ABRLD:Yes

Expired US Patents for NDA 017563

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

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