AFINITOR از شرکت NOVARTIS

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AFINITOR از شرکت NOVARTIS

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

AB

Yes Yes
AFINITOR EVEROLIMUS 10MG TABLET;ORAL Prescription

AB

Yes No
AFINITOR EVEROLIMUS 2.5MG TABLET;ORAL Prescription

AB

Yes No
AFINITOR EVEROLIMUS 7.5MG TABLET;ORAL Prescription

AB

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
04/16/2021 SUPPL-47 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022334Orig1s047, 203985Orig1s020ltr.pdf

01/22/2020 SUPPL-45 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022334Orig1s045,203985Orig1s017ltr.pdf

02/13/2020 SUPPL-44 Labeling-Package Insert, Labeling-Patient Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022334Orig1s044, 203985Orig1s016ltr.pdf

04/10/2018 SUPPL-40 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022334Orig1s040,203985Orig1s013ltr.pdf

09/26/2017 SUPPL-39 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022334s039lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022334Orig1s039ltr.pdf

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-Patient Package Insert, 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-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
04/16/2021 SUPPL-47

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf
02/13/2020 SUPPL-44

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf
02/13/2020 SUPPL-44

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf
01/22/2020 SUPPL-45

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf
04/10/2018 SUPPL-40

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf
09/26/2017 SUPPL-39

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022334s039lbl.pdf
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-Patient 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-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

AFINITOR

TABLET;ORAL; 5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 5MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
EVEROLIMUS EVEROLIMUS 5MG TABLET;ORAL Prescription No AB 210050 TEVA PHARMS USA

TABLET;ORAL; 10MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 10MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 10MG TABLET;ORAL Prescription No AB 207934 PAR PHARM

TABLET;ORAL; 2.5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 2.5MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
EVEROLIMUS EVEROLIMUS 2.5MG TABLET;ORAL Prescription No AB 210050 TEVA PHARMS USA

TABLET;ORAL; 7.5MG

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AFINITOR EVEROLIMUS 7.5MG TABLET;ORAL Prescription Yes AB 022334 NOVARTIS
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 205426 BRECKENRIDGE
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 207486 HIKMA
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 212936 MYLAN
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 207934 PAR PHARM
EVEROLIMUS EVEROLIMUS 7.5MG TABLET;ORAL Prescription No AB 210050 TEVA PHARMS USA
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