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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 is included in two NDAs. It is available from six 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-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.

Summary for NDA: 022127

sevelamer carbonate
Therapeutic Class:Genitourinary Agents

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
sevelamer carbonate
TABLET;ORAL 022127 NDA AUTHORIZED GENERIC Global Pharmaceuticals Division of IMPAX Laboratories, Inc. 0115-1494 0115-1494-27 270 TABLET, FILM COATED in 1 BOTTLE (0115-1494-27)
sevelamer carbonate
TABLET;ORAL 022127 NDA KAISER FOUNDATION HOSPITALS 0179-0043 0179-0043-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0043-70)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Oct 19, 2007TE:RLD:Yes
Patent:7,985,418Patent Expiration:Oct 27, 2025Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022127

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 20075,496,545► subscribe
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 20077,014,846► subscribe
sevelamer carbonate
TABLET;ORAL022127-001Oct 19, 20076,509,013► subscribe
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