Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022334
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AFINITOR EVEROLIMUS 5MG TABLET;ORAL Prescription None Yes No
AFINITOR EVEROLIMUS 10MG TABLET;ORAL Prescription None Yes Yes
AFINITOR EVEROLIMUS 2.5MG TABLET;ORAL Prescription None Yes No
AFINITOR EVEROLIMUS 7.5MG TABLET;ORAL 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
03/30/2009 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022334s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022334s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/14/2016 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s038ltr.pdf
02/26/2016 SUPPL-36 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s036ltr.pdf
02/18/2016 SUPPL-35 Efficacy-Accelerated Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s035ltr.pdf
02/04/2016 SUPPL-34 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s034ltr.pdf
01/29/2016 SUPPL-32 Efficacy-Accelerated Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022334Orig1s032,203985Orig1s010ltr.pdf
09/18/2015 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s031ltr.pdf
05/22/2015 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s030ltr.pdf
01/23/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022334Orig1s029ltr.pdf
10/20/2014 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/18/2014 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s027ltr.pdf
09/12/2014 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

07/01/2014 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s025,203985Orig1s007ltr.pdf
02/20/2014 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf
02/20/2014 SUPPL-23 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf
11/06/2013 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022334Orig1s022,203985Orig1s003ltr.pdf
02/20/2014 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022334Orig1s021,023,024,203985Orig1s002,004,005_replace_ltr.pdf
06/21/2013 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/26/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/29/2012 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s018ltr.pdf
04/26/2012 SUPPL-17 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s017ltr.pdf
07/20/2012 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334Orig1s016ltrRepl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022334Orig1s016.pdf
03/30/2012 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf
03/30/2012 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022334s014,s015ltr.pdf
05/05/2011 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf
05/05/2011 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022334s009,s010ltr.pdf
10/29/2010 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s006ltr.pdf
07/09/2010 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

07/09/2010 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s004ltr.pdf
05/13/2010 SUPPL-1 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022334s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/14/2016 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s038lbl.pdf
02/26/2016 SUPPL-36 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s036lbl.pdf
02/04/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf
02/04/2016 SUPPL-34 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s034lbl.pdf
01/29/2016 SUPPL-32 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf
09/18/2015 SUPPL-31 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s031lbl.pdf
05/22/2015 SUPPL-30 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s030lbl.pdf
01/23/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022334s029lbl.pdf
12/18/2014 SUPPL-27 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf
07/01/2014 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf
02/20/2014 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
02/20/2014 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
02/20/2014 SUPPL-23 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
02/20/2014 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
11/06/2013 SUPPL-22 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf
08/29/2012 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf
07/20/2012 SUPPL-16 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s016lbl.pdf
04/26/2012 SUPPL-17 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s017lbl.pdf
03/30/2012 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf
03/30/2012 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf
05/05/2011 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf
05/05/2011 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf
10/29/2010 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf
07/09/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf
05/13/2010 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf
03/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf

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