Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021968
Company: CPPI CV
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 |