Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020926
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RENAGEL SEVELAMER HYDROCHLORIDE 403MG CAPSULE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/30/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20926lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20926ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020926.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/06/2004 SUPPL-6 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
08/08/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/15/2002 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

10/13/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/05/2000 SUPPL-2 Efficacy-New Dosing Regimen Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20926S2LTR.PDF
10/01/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/30/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20926lbl.pdf

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