Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202714
Company: ONYX THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KYPROLIS CARFILZOMIB 60MG/VIAL POWDER;INTRAVENOUS Prescription None Yes Yes
KYPROLIS CARFILZOMIB 30MG/VIAL POWDER;INTRAVENOUS Prescription None Yes No
KYPROLIS CARFILZOMIB 10MG/VIAL POWDER;INTRAVENOUS Prescription None Yes 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
07/20/2012 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202714Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202714Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/28/2019 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202714s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202714Orig1s025ltr.pdf
09/28/2018 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s021ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/202714Orig1s021TOC.cfm
06/07/2018 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s019ltr.pdf
01/17/2018 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202714Orig1s017ltr.pdf
05/25/2017 SUPPL-16 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202714Orig1s016ltr.pdf
11/17/2016 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s015ltr.pdf
11/21/2016 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/04/2016 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s013ltr.pdf
06/03/2016 SUPPL-12 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714s012ltr.pdf
05/23/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s011ltr.pdf
01/21/2016 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202714Orig1s010ltr.pdf
07/24/2015 SUPPL-9 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s009ltr.pdf
03/27/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202714Orig1s008ltr.pdf
04/24/2015 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/21/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/03/2014 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

06/02/2014 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/31/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/19/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/21/2013 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/28/2019 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202714s025lbl.pdf
09/28/2018 SUPPL-21 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s021lbl.pdf
06/07/2018 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s019lbl.pdf
01/17/2018 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202714s017lbl.pdf
05/25/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf
05/25/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202714s016lbl.pdf
11/17/2016 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s015lbl.pdf
08/04/2016 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s013lbl.pdf
06/03/2016 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s012lbl.pdf
05/23/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s011lbl.pdf
01/21/2016 SUPPL-10 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202714s010lbl.pdf
07/24/2015 SUPPL-9 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s009lbl.pdf
03/27/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202714s008lbl.pdf
07/20/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202714lbl.pdf

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