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Last Updated: November 30, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021179

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NDA 021179 describes RENAGEL, which is a drug marketed by Genzyme and is included in two NDAs. It is available from two suppliers. Additional details are available on the RENAGEL profile page.

The generic ingredient in RENAGEL is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
Summary for 021179
Ingredient:sevelamer hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 021179
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 021179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RENAGEL sevelamer hydrochloride TABLET;ORAL 021179 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1048 0955-1048-18 180 TABLET, FILM COATED in 1 BOTTLE (0955-1048-18)
RENAGEL sevelamer hydrochloride TABLET;ORAL 021179 NDA Genzyme Corporation 58468-0021 58468-0021-1 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58468-0021-1)
Paragraph IV (Patent) Challenges for 021179
Tradename Dosage Ingredient NDA Submissiondate
RENAGEL TABLET;ORAL sevelamer hydrochloride 021179 2008-05-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jul 12, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jul 12, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021179

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