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General MedicationsORALStandard

COTELLIC

COBIMETINIB FUMARATE

Standard Dose
EQ 20MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview COTELLIC is listed in Drugs@FDA under application 206192 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient COBIMETINIB FUMARATE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor GENENTECH INC Submission history Latest submission status date: 2023-05-31 00:00:00.

Structured Monograph

Clinical summary

Approval overview COTELLIC is listed in Drugs@FDA under application 206192 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient COBIMETINIB FUMARATE Form and strength TABLET;ORAL - EQ 20MG BASE Sponsor GENENTECH INC Submission history Latest submission status date: 2023-05-31 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
COTELLIC (COBIMETINIB FUMARATE) | Drug Monograph | MedicHelpline