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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021968
Company: CPPI CV

Products on NDA 021968

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SUTENT	SUNITINIB MALATE	EQ 12.5MG BASE	CAPSULE; ORAL	Prescription	None	No	No
SUTENT	SUNITINIB MALATE	EQ 25MG BASE	CAPSULE; ORAL	Prescription	None	No	No
SUTENT	SUNITINIB MALATE	EQ 50MG BASE	CAPSULE; ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021968

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2006	ORIG-1	Approval	Type 6 - New Indication (no longer used)	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021968s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021938s000_021968s000_Stutent.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2007	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s006_sutent.pdf
02/02/2007	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s005_sutent.pdf
02/02/2007	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s004_sutent.pdf
02/02/2007	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s003_sutent.pdf
02/02/2007	SUPPL-2	Labeling	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021938s2s3s4s5,021968s2s3s4s5s6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021968_s002_sutent.pdf
05/10/2006	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 021968

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2007	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf
02/02/2007	SUPPL-5	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf
02/02/2007	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf
02/02/2007	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf
02/02/2007	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021968s002s003s004s005s006lbl.pdf
01/26/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021968lbl.pdf

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