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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022088
Company: PF PRISM CV

Products on NDA 022088

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TORISEL	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022088

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/30/2007	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022088s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022088s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2018	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022088Orig1s021s023ltr.pdf
03/23/2018	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022088Orig1s021s023ltr.pdf
05/22/2017	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022088s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022088Orig1s020ltr.pdf
07/27/2016	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022088s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022088Orig1s019ltr.pdf
02/26/2015	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022088s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022088Orig1s018ltr.pdf
10/07/2014	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022088Orig1s017ltr.pdf
04/07/2014	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022088Orig1s016ltr.pdf
12/20/2013	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/30/2012	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022088s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022088s014ltr.pdf
06/16/2011	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf
06/16/2011	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf
07/09/2010	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022088s008ltr.pdf
06/16/2011	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf
04/26/2010	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022088s006ltr.pdf
06/16/2011	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf
06/16/2011	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf
06/16/2011	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022088s002,s004,s005,s007,s010,s012ltr.pdf
11/09/2007	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022088s001ltr.pdf

Labels for NDA 022088

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2018	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf
03/23/2018	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022088s021s023lbl.pdf
05/22/2017	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022088s020lbl.pdf
07/27/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022088s019lbl.pdf
02/26/2015	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022088s018lbl.pdf
10/07/2014	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s017lbl.pdf
04/07/2014	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022088s016lbl.pdf
05/30/2012	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022088s014lbl.pdf
06/16/2011	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf
06/16/2011	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf
06/16/2011	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf
06/16/2011	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf
06/16/2011	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf
06/16/2011	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022088s002s004s005s007s010s012lbl.pdf
07/09/2010	SUPPL-8	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s008lbl.pdf
04/26/2010	SUPPL-6	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022088s006lbl.pdf
11/09/2007	SUPPL-1	Manufacturing (CMC)-Packaging	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088s001lbl.pdf
05/30/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022088lbl.pdf

Therapeutic Equivalents for NDA 022088

TORISEL

SOLUTION;INTRAVENOUS; 25MG/ML (25MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TEMSIROLIMUS	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	203153	ACCORD HLTHCARE
TEMSIROLIMUS	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	207383	GLAND PHARMA LTD
TORISEL	TEMSIROLIMUS	25MG/ML (25MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	022088	PF PRISM CV

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