Drugs@FDA: FDA Approved Drug Products

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

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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