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Last Updated: April 25, 2024

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 three 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-seven 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 Action	Phosphate 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	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1050	0955-1050-27	270 TABLET, FILM COATED in 1 BOTTLE (0955-1050-27)
RENVELA	sevelamer carbonate	TABLET;ORAL	022127	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1057	0955-1057-30	270 TABLET, FILM COATED in 1 BOTTLE (0955-1057-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Oct 19, 2007	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Oct 27, 2025	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022127

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

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