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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215223


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NDA 215223 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 215223
Tradename:COLESTIPOL HYDROCHLORIDE
Applicant:Zydus Pharms
Ingredient:colestipol hydrochloride
Patents:0
Pharmacology for NDA: 215223
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 215223
Suppliers and Packaging for NDA: 215223
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLESTIPOL HYDROCHLORIDE colestipol hydrochloride TABLET;ORAL 215223 ANDA Zydus Pharmaceuticals USA Inc. 70710-1467 70710-1467-5 500 TABLET, FILM COATED in 1 BOTTLE (70710-1467-5)
COLESTIPOL HYDROCHLORIDE colestipol hydrochloride TABLET;ORAL 215223 ANDA Zydus Pharmaceuticals USA Inc. 70710-1467 70710-1467-7 120 TABLET, FILM COATED in 1 BOTTLE (70710-1467-7)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1GM
Approval Date:Mar 10, 2022TE:ABRLD:No

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