Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021179
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENAGEL SEVELAMER HYDROCHLORIDE 400MG TABLET;ORAL Prescription None Yes No
RENAGEL SEVELAMER HYDROCHLORIDE 800MG TABLET;ORAL Prescription None 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
07/12/2000 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21179lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21179ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-179_Renagel.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2016 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021179s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021179Orig1s032ltr.pdf
06/09/2015 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/26/2014 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021179Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021179Orig1s030ltr.pdf
06/16/2011 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021179s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021179s029,022127s008,022318s003ltr.pdf
08/14/2007 SUPPL-21 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s021LTR.pdf
10/19/2007 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021179s020ltr.pdf
07/25/2005 SUPPL-15 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021179s015ltr.pdf
01/07/2003 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/06/2004 SUPPL-2 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20926se1-006,21179se1-002ltr.pdf
03/15/2002 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/09/2016 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021179s032lbl.pdf
11/26/2014 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021179Orig1s030lbl.pdf
06/16/2011 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021179s029lbl.pdf
10/19/2007 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s020lbl.pdf
08/14/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021179s021lbl.pdf
07/12/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21179lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English