AFINITOR DISPERZ از شرکت NOVARTIS PHARM

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 DISPERZ از شرکت NOVARTIS PHARM

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
04/16/2021 SUPPL-20 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-17 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-16 Labeling-Patient Package Insert, Labeling-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-13 Efficacy-New Indication

Label (PDF)

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

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
04/16/2021 SUPPL-20

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf
02/13/2020 SUPPL-16

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf
02/13/2020 SUPPL-16

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf
01/22/2020 SUPPL-17

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf
04/10/2018 SUPPL-13

Efficacy-New Indication

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf
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
بخوانید  CYCLOPHOSPHAMIDE از شرکت HIKMA
به بالای صفحه بردن