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General MedicationsORALStandard

XATMEP

METHOTREXATE SODIUM

Standard Dose
EQ 2.5MG BASE/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Prescription
Summary

Approval overview XATMEP is listed in Drugs@FDA under application 208400 (NDA).

Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient METHOTREXATE SODIUM Form and strength SOLUTION;ORAL - EQ 2.5MG BASE/ML Sponsor AZURITY Submission history Latest submission status date: 2018-03-15 00:00:00.

Structured Monograph

Clinical summary

Approval overview XATMEP is listed in Drugs@FDA under application 208400 (NDA). Review priority: 901 REQUIRED Marketing status: Prescription Active ingredient METHOTREXATE SODIUM Form and strength SOLUTION;ORAL - EQ 2.5MG BASE/ML Sponsor AZURITY Submission history Latest submission status date: 2018-03-15 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.