Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022318

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RENVELA (SEVELAMER CARBONATE)
800MG/PACKET
Marketing Status: Prescription

Active Ingredient: SEVELAMER CARBONATE
Proprietary Name: RENVELA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 800MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022318
Product Number: 001
Approval Date: Aug 12, 2009
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

RENVELA (SEVELAMER CARBONATE)
2.4GM/PACKET
Marketing Status: Prescription

Active Ingredient: SEVELAMER CARBONATE
Proprietary Name: RENVELA
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 2.4GM/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022318
Product Number: 002
Approval Date: Feb 18, 2009
Applicant Holder Full Name: GENZYME CORP
Marketing Status:  Prescription
Patent and Exclusivity Information