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General MedicationsORALStandard

KISQALI FEMARA CO-PACK (COPACKAGED)

LETROZOLE; RIBOCICLIB SUCCINATE

Standard Dose
2.5MG;EQ 200MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: N/A Marketing status: Prescription
Summary

Approval overview KISQALI FEMARA CO-PACK (COPACKAGED) is listed in Drugs@FDA under application 209935 (NDA).

Review priority: N/A Marketing status: Prescription Active ingredient LETROZOLE; RIBOCICLIB SUCCINATE Form and strength TABLET;ORAL - 2.5MG;EQ 200MG BASE Sponsor NOVARTIS Submission history Latest submission status date: 2025-09-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview KISQALI FEMARA CO-PACK (COPACKAGED) is listed in Drugs@FDA under application 209935 (NDA). Review priority: N/A Marketing status: Prescription Active ingredient LETROZOLE; RIBOCICLIB SUCCINATE Form and strength TABLET;ORAL - 2.5MG;EQ 200MG BASE Sponsor NOVARTIS Submission history Latest submission status date: 2025-09-16 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: N/A

Interaction Notes

  • No interaction notes stored yet.