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 |
| 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 |