Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203496
Company: UNITED THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ORENITRAM TREPROSTINIL DIOLAMINE EQ 0.125MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
ORENITRAM TREPROSTINIL DIOLAMINE EQ 0.25MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
ORENITRAM TREPROSTINIL DIOLAMINE EQ 1MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
ORENITRAM TREPROSTINIL DIOLAMINE EQ 2.5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
ORENITRAM TREPROSTINIL DIOLAMINE EQ 5MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/20/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203496Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203496Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2019 SUPPL-11 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203496s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203496Orig1s011ltr.pdf
06/07/2017 SUPPL-7 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s007ltr.pdf
01/24/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203496Orig1s006ltr.pdf
01/28/2016 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203496Orig1s002ltr.pdf
10/06/2014 SUPPL-1 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203496Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/18/2019 SUPPL-11 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203496s011lbl.pdf
06/07/2017 SUPPL-7 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s007lbl.pdf
01/24/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203496s006lbl.pdf
01/28/2016 SUPPL-2 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203496s002lbl.pdf
10/06/2014 SUPPL-1 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203496s001lbl.pdf
12/20/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203496Orig1s000lbl_edt.pdf

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