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General MedicationsINTRACAVITARY, INTRAVENOUS, INTRAVESICALStandard

THIOTEPA

THIOTEPA

Standard Dose
15MG/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview THIOTEPA is listed in Drugs@FDA under application 217559 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient THIOTEPA Form and strength POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL - 15MG/VIAL Sponsor REGCON HOLDINGS Submission history Latest submission status date: 2024-08-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview THIOTEPA is listed in Drugs@FDA under application 217559 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient THIOTEPA Form and strength POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL - 15MG/VIAL Sponsor REGCON HOLDINGS Submission history Latest submission status date: 2024-08-20 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.