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General MedicationsORALGeneric

TEMOZOLOMIDE

TEMOZOLOMIDE

Standard Dose
100MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued

Key Takeaways

  • Primary indication: Review priority: STANDARD Marketing status: Discontinued
  • Approval overview TEMOZOLOMIDE is listed in Drugs@FDA under application 213328 (ANDA).
  • Review priority: STANDARD Marketing status: Discontinued Active ingredient TEMOZOLOMIDE Form and strength CAPSULE;ORAL - 100MG Sponsor NIVAGEN PHARMS INC Submission history Latest submission status date: 2021-11-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview TEMOZOLOMIDE is listed in Drugs@FDA under application 213328 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient TEMOZOLOMIDE Form and strength CAPSULE;ORAL - 100MG Sponsor NIVAGEN PHARMS INC Submission history Latest submission status date: 2021-11-23 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.