General MedicationsINTRAVENOUS, SUBCUTANEOUSGeneric
REMODULIN
TREPROSTINIL
Standard Dose
200MG/20ML (10MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview REMODULIN is listed in Drugs@FDA under application 208276 (NDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient TREPROSTINIL Form and strength SOLUTION;INTRAVENOUS, SUBCUTANEOUS - 200MG/20ML (10MG/ML) Sponsor UNITED THERAP Submission history Latest submission status date: 2018-07-30 00:00:00.
Structured Monograph
Clinical summary
Approval overview REMODULIN is listed in Drugs@FDA under application 208276 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TREPROSTINIL Form and strength SOLUTION;INTRAVENOUS, SUBCUTANEOUS - 200MG/20ML (10MG/ML) Sponsor UNITED THERAP Submission history Latest submission status date: 2018-07-30 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.