Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022387
Company: UNITED THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TYVASO TREPROSTINIL 0.6MG/ML SOLUTION;INHALATION Prescription None 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
07/30/2009 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022387s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/19/2017 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022387Orig1s015ltr.pdf
06/06/2016 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022387Orig1s014ltr.pdf
06/23/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/01/2014 SUPPL-11 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

05/20/2014 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022387Orig1s009ltr.pdf
04/30/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf
01/07/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/08/2011 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/19/2017 SUPPL-15 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s015lbl.pdf
06/06/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf
05/20/2014 SUPPL-9 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf
04/30/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf
02/08/2011 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf
07/30/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf

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