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General MedicationsINTRAVENOUSStandard

AXTLE

PEMETREXED DIPOTASSIUM

Standard Dose
EQ 500MG BASE/VIAL
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview AXTLE is listed in Drugs@FDA under application 210661 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PEMETREXED DIPOTASSIUM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2025-10-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview AXTLE is listed in Drugs@FDA under application 210661 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PEMETREXED DIPOTASSIUM Form and strength POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL Sponsor AVYXA HOLDINGS Submission history Latest submission status date: 2025-10-03 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.