Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022088
Company: PF PRISM CV
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 |