Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020926
Company: GENZYME

Products on NDA 020926

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RENAGEL	SEVELAMER HYDROCHLORIDE	403MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020926

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.

Labels for NDA 020926

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