Skip to main content
MedicHelpLine
Join Free
Verified Professional Network190+ CountriesHIPAA-Aware Platform
Back to Drug Index
General MedicationsORALStandard

ORENITRAM

TREPROSTINIL DIOLAMINE

Standard Dose
EQ 2.5MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview ORENITRAM is listed in Drugs@FDA under application 203496 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TREPROSTINIL DIOLAMINE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 2.5MG BASE Sponsor UNITED THERAP Submission history Latest submission status date: 2020-11-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview ORENITRAM is listed in Drugs@FDA under application 203496 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TREPROSTINIL DIOLAMINE Form and strength TABLET, EXTENDED RELEASE;ORAL - EQ 2.5MG BASE Sponsor UNITED THERAP Submission history Latest submission status date: 2020-11-03 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.