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General MedicationsINTRAVENOUS, SUBCUTANEOUSStandard

TREPROSTINIL

TREPROSTINIL

Standard Dose
5MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview TREPROSTINIL is listed in Drugs@FDA under application 211574 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TREPROSTINIL Form and strength INJECTABLE;INTRAVENOUS, SUBCUTANEOUS - 5MG/ML Sponsor ALEMBIC GLOBAL Submission history Latest submission status date: 2021-02-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview TREPROSTINIL is listed in Drugs@FDA under application 211574 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TREPROSTINIL Form and strength INJECTABLE;INTRAVENOUS, SUBCUTANEOUS - 5MG/ML Sponsor ALEMBIC GLOBAL Submission history Latest submission status date: 2021-02-11 00:00:00. Submission type: ORIG.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.