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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203985
Company: NOVARTIS PHARM

Summary Review

Products on NDA 203985

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AFINITOR DISPERZ	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	Yes	No
AFINITOR DISPERZ	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	Yes	No
AFINITOR DISPERZ	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203985

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
03/11/2024	SUPPL-27	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203985Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203985Orig1s027ltr.pdf
02/01/2022	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203985s023,022334s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203985Orig1s023; 022334Orig1s051ltr.pdf
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.

Labels for NDA 203985

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/11/2024	SUPPL-27	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203985Orig1s027lbl.pdf
02/01/2022	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203985s023,022334s051lbl.pdf
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

Therapeutic Equivalents for NDA 203985

AFINITOR DISPERZ

TABLET, FOR SUSPENSION;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR DISPERZ	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	203985	NOVARTIS PHARM
EVEROLIMUS	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210130	MYLAN

TABLET, FOR SUSPENSION;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR DISPERZ	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	203985	NOVARTIS PHARM
EVEROLIMUS	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210130	MYLAN

TABLET, FOR SUSPENSION;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR DISPERZ	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	203985	NOVARTIS PHARM
EVEROLIMUS	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	210130	MYLAN

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