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Generated: November 13, 2018

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Details for New Drug Application (NDA): 022127

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NDA 022127 describes RENVELA, which is a drug marketed by Genzyme and Sanofi and is included in two NDAs. It is available from five suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the RENVELA profile page.

The generic ingredient in RENVELA is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 022127
Tradename:RENVELA
Applicant:Sanofi
Ingredient:sevelamer carbonate
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022127
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 022127
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RENVELA sevelamer carbonate TABLET;ORAL 022127 NDA AUTHORIZED GENERIC KAISER FOUNDATION HOSPITALS 0179-0236 0179-0236-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0236-70)
RENVELA sevelamer carbonate TABLET;ORAL 022127 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1050 0955-1050-27 270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Oct 19, 2007TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Nov 25, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Try a Free TrialPatent Expiration:Oct 27, 2025Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022127

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi RENVELA sevelamer carbonate TABLET;ORAL 022127-001 Oct 19, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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