Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022318
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENVELA SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription AB Yes No
RENVELA SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/12/2009 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022318lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022318s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_renvela_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022318s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/25/2016 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s015,022318s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s015, 022318Orig1s008ltr.pdf
03/09/2016 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022127Orig1s013,022318Orig1s006ltr.pdf
11/26/2014 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022127Orig1s011,022318Orig1s005ltr.pdf
06/16/2011 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/25/2016 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s015,022318s008lbl.pdf
03/09/2016 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022127s013,022318s006lbl.pdf
11/26/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022127s011lbl.pdf
06/16/2011 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022318s003,022127s008lbl.pdf
08/12/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022318lbl.pdf

RENVELA

FOR SUSPENSION;ORAL; 800MG/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENVELA SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 022318 GENZYME
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 207624 AUROBINDO PHARMA LTD
SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION;ORAL Prescription No AB 210464 DR REDDYS LABS LTD

FOR SUSPENSION;ORAL; 2.4GM/PACKET
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RENVELA SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription Yes AB 022318 GENZYME
SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 207624 AUROBINDO PHARMA LTD
SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION;ORAL Prescription No AB 210464 DR REDDYS LABS LTD

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