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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022318
Company: GENZYME

Summary Review

Products on NDA 022318

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022318

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
04/30/2020	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022127s019,022318s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022127Orig1s019,022318Orig1s012ltr.pdf
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

Labels for NDA 022318

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2020	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022127s019,022318s021lbl.pdf
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

Therapeutic Equivalents for NDA 022318

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
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	209374	BIONPHARMA
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	217319	CHARTWELL RX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	210464	DR REDDYS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211316	IMPAX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	207291	MACLEODS PHARMS LTD
SEVELAMER CARBONATE	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211917	STRIDES PHARMA

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
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	217319	CHARTWELL RX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	210464	DR REDDYS
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211316	IMPAX
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	207291	MACLEODS PHARMS LTD
SEVELAMER CARBONATE	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION;ORAL	Prescription	No	AB	211917	STRIDES PHARMA

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