`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 022387
`Company: UNITED THERAP
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
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`Usage Instructions (http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387UsageInstr.pdf)
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`Products on NDA 022387
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`CSVExcelPrint
`Drug
`Active
`Name
`Ingredients
`
`TREPROSTINIL
`TYVASO
`Showing 1 to 1 of 1 entries
`
`Strength
`
`Dosage Form/Route
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`0.6MG/ML
`
`SOLUTION;INHALATION
`
`Prescription
`
`Yes
`
`None
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 022387
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
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`
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`Drugs@FDA: FDA Approved Drug Products
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`07/30/2009 ORIG1
`
`Approval
`
`Type 5 New
`Formulation or
`New
`Manufacturer
`
`Review
`Priority;
`Orphan
`Status
`
`Letters, Reviews, Labels, Patient Package Insert
`
`STANDARD
`;
`Orphan
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022387LBL.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022387s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022387s000TOC.cfm)
`
`Showing 1 to 1 of 1 entries
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`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`06/06/2016 SUPPL14
`
`Submission
`Classification
`
`Labeling
`Package Insert
`
`06/23/2015 SUPPL12
`
`Manufacturing
`(CMC)
`
`08/01/2014 SUPPL11
`
`05/20/2014 SUPPL9
`
`04/30/2013 SUPPL8
`
`Labeling
`Package Insert,
`Labeling
`Container/Carton
`Labels, Labeling
`Patient Package
`Insert
`
`EfficacyLabeling
`Change With
`Clinical Data
`
`Labeling
`Package Insert
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022387s014lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022387Orig1s014ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022387s009lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022387Orig1s009ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022387s008lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022387Orig1s008ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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`Drugs@FDA: FDA Approved Drug Products
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`Action
`Date
`
`Submission
`
`Submission
`Classification
`
`01/07/2013 SUPPL7
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`02/08/2011
`
`SUPPL4
`
`Labeling
`Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022387s004lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022387s004ltr.pdf)
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`Showing 1 to 7 of 7 entries
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`Labels for NDA 022387
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`
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