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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021179
Company: GENZYME

Products on NDA 021179

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RENAGEL	SEVELAMER HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	AB	Yes	No
RENAGEL	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021179

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
04/30/2020	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021179s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021179Orig1s038ltr.pdf
02/21/2019	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021179s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021179Orig1s037ltr.pdf
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.

Labels for NDA 021179

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2020	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021179s038lbl.pdf
02/21/2019	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021179s037lbl.pdf
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

Therapeutic Equivalents for NDA 021179

RENAGEL

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RENAGEL	SEVELAMER HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	Yes	AB	021179	GENZYME
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	204724	GLENMARK PHARMS LTD
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	213145	LUPIN LTD
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	400MG	TABLET;ORAL	Prescription	No	AB	206883	MACLEODS PHARMS LTD

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
RENAGEL	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	Yes	AB	021179	GENZYME
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	No	AB	204724	GLENMARK PHARMS LTD
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	No	AB	213145	LUPIN LTD
SEVELAMER HYDROCHLORIDE	SEVELAMER HYDROCHLORIDE	800MG	TABLET;ORAL	Prescription	No	AB	206883	MACLEODS PHARMS LTD

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