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General MedicationsINTRAVENOUSStandard

NELARABINE

NELARABINE

Standard Dose
375MG/75ML (5MG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NELARABINE is listed in Drugs@FDA under application 214809 (ANDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient NELARABINE Form and strength INJECTABLE;INTRAVENOUS - 375MG/75ML (5MG/ML) Sponsor SHORLA Submission history Latest submission status date: 2023-03-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview NELARABINE is listed in Drugs@FDA under application 214809 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient NELARABINE Form and strength INJECTABLE;INTRAVENOUS - 375MG/75ML (5MG/ML) Sponsor SHORLA Submission history Latest submission status date: 2023-03-03 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.