Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021560
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZORTRESS EVEROLIMUS 0.25MG TABLET;ORAL Prescription AB Yes No
ZORTRESS EVEROLIMUS 0.5MG TABLET;ORAL Prescription AB Yes No
ZORTRESS EVEROLIMUS 0.75MG TABLET;ORAL Prescription AB 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
04/20/2010 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021560s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021560s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000_zortress_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021560s000sumr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/12/2018 SUPPL-21 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf
01/12/2018 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021560Orig1s020ltr.pdf
10/12/2016 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021560s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021560Orig1s019ltr.pdf
11/05/2015 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s018ltr.pdf
03/01/2016 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

06/24/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/14/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/05/2013 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021560Orig1s011ltr.pdf
03/26/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/02/2012 SUPPL-9 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560s009ltr.pdf
10/02/2012 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s008ltr.pdf
04/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021560Orig1s007ltr.pdf
02/15/2013 SUPPL-6 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021560Orig1s006ltr.pdf
11/21/2011 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021560s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/12/2018 SUPPL-21 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf
01/12/2018 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s021lbl.pdf
01/12/2018 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021560s020lbl.pdf
10/12/2016 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021560s019lbl.pdf
11/05/2015 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s018lbl.pdf
01/27/2015 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021560s011lbl.pdf
02/15/2013 SUPPL-6 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021560s006lbl.pdf
10/02/2012 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s008lbl.pdf
04/26/2012 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021560s007lbl.pdf
04/20/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021560s000lbl.pdf

ZORTRESS

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 0.25MG TABLET;ORAL Prescription No AB 206133 WEST-WARD PHARMS INT
ZORTRESS EVEROLIMUS 0.25MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 0.5MG TABLET;ORAL Prescription No AB 206133 WEST-WARD PHARMS INT
ZORTRESS EVEROLIMUS 0.5MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVEROLIMUS EVEROLIMUS 0.75MG TABLET;ORAL Prescription No AB 206133 WEST-WARD PHARMS INT
ZORTRESS EVEROLIMUS 0.75MG TABLET;ORAL Prescription Yes AB 021560 NOVARTIS

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