Drugs@FDA: FDA-Approved Drugs

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

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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