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Generated: May 26, 2019

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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 six suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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. Seven suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
Summary for 021179
Tradename:RENAGEL
Applicant:Genzyme
Ingredient:sevelamer hydrochloride
Patents:1
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 Atlantic Biologicals Corps 17856-0021 17856-0021-2 1 TABLET in 1 POUCH (17856-0021-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Jul 12, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 18, 2020Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jul 12, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 18, 2020Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021179

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-001 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Genzyme RENAGEL sevelamer hydrochloride TABLET;ORAL 021179-002 Jul 12, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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