`
`Drugs@FDA: FDA Approved Drug Products
`
`Drugs@FDA: FDA Approved Drug
`Products
`
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`New Drug Application (NDA): 203496
`Company: UNITED THERAP
`
` EMAIL (MAILTO:?SUBJECT=DRUGS@FDA: FDA APPROVED DRUG
`PRODUCTS&BODY=HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDER/DAF/INDEX.CFM?EVENT=OVERVIEW.PROCESS%26VARAPPLNO=203496)
`
`Products on NDA 203496
`
`CSVExcelPrint
`
`Drug Name
`
`ORENITRAM
`
`ORENITRAM
`
`ORENITRAM
`
`ORENITRAM
`
`Active
`Ingredients
`
`TREPROSTINIL
`DIOLAMINE
`
`TREPROSTINIL
`DIOLAMINE
`
`TREPROSTINIL
`DIOLAMINE
`
`TREPROSTINIL
`DIOLAMINE
`
`ORENITRAM
`
`TREPROSTINIL
`DIOLAMINE
`Showing 1 to 5 of 5 entries
`
`
`
`Strength
`
`Dosage Form/Route
`
`EQ 0.125MG
`BASE
`
`TABLET, EXTENDED
`RELEASE;ORAL
`
`EQ 0.25MG
`BASE
`
`TABLET, EXTENDED
`RELEASE;ORAL
`
`EQ 1MG BASE
`
`TABLET, EXTENDED
`RELEASE;ORAL
`
`EQ 2.5MG
`BASE
`
`TABLET, EXTENDED
`RELEASE;ORAL
`
`EQ 5MG BASE
`
`TABLET, EXTENDED
`RELEASE;ORAL
`
`Marketing
`Status
`
`TE
`Code
`
`RLD
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
`Prescription
`
`Yes
`
`None
`
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`Drugs@FDA: FDA Approved Drug Products
`
`Approval Date(s) and History, Letters, Labels, Reviews for NDA 203496
`
`
`
`Original Approvals or Tentative Approvals
`CSVExcelPrint
`
`Action
`Date
`
`Submission
`
`Action
`Type
`
`Submission
`Classification
`
`12/20/2013 ORIG1
`
`Approval
`
`Type 3 New
`Dosage Form
`
`Review
`Priority;
`Orphan
`Status
`
`STANDARD
`;
`Orphan
`
`Letters, Reviews, Labels, Patient Package Insert
`
`Label (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf)
`Letter (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf)
`Review (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000TOC.cfm)
`Summary Review (PDF) (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf)
`
`Showing 1 to 1 of 1 entries
`
`Supplements
`CSVExcelPrint
`Action
`Date
`
`Submission
`
`01/24/2017 SUPPL6
`
`01/28/2016 SUPPL2
`
`10/06/2014 SUPPL1
`
`Showing 1 to 3 of 3 entries
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`Labels for NDA 203496
`
`Submission
`Classification
`
`Labeling
`Package Insert
`
`Efficacy
`Labeling
`Change With
`Clinical Data
`
`Manufacturing
`(CMC)
`
`Letters, Reviews, Labels,
`Patient Package Insert
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s006ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf)
`
`Label (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf)
`Letter (PDF)
`(https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf)
`
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
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