Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203985
Company: NOVARTIS PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AFINITOR DISPERZ EVEROLIMUS 2MG TABLET, FOR SUSPENSION;ORAL Prescription None Yes No
AFINITOR DISPERZ EVEROLIMUS 3MG TABLET, FOR SUSPENSION;ORAL Prescription None Yes No
AFINITOR DISPERZ EVEROLIMUS 5MG TABLET, FOR SUSPENSION;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/2012 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203985Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985_afinitor_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203985Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/29/2016 SUPPL-10 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
08/24/2015 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/23/2015 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203985Orig1s008ltr.pdf
07/01/2014 SUPPL-7 Labeling-Package Insert, 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
07/01/2015 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/20/2014 SUPPL-5 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-4 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
11/06/2013 SUPPL-3 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-2 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
03/26/2013 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
01/29/2016 SUPPL-10 Efficacy-Accelerated Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf
01/23/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf
07/01/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf
07/01/2014 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf
02/20/2014 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
02/20/2014 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
02/20/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
11/06/2013 SUPPL-3 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf
08/29/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf

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