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General MedicationsORALStandard

COBENFY

TROSPIUM CHLORIDE; XANOMELINE TARTRATE

Standard Dose
20MG;EQ 100MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview COBENFY is listed in Drugs@FDA under application 216158 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TROSPIUM CHLORIDE; XANOMELINE TARTRATE Form and strength CAPSULE;ORAL - 20MG;EQ 100MG BASE Sponsor BRISTOL-MYERS Submission history Latest submission status date: 2024-09-26 00:00:00.

Structured Monograph

Clinical summary

Approval overview COBENFY is listed in Drugs@FDA under application 216158 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TROSPIUM CHLORIDE; XANOMELINE TARTRATE Form and strength CAPSULE;ORAL - 20MG;EQ 100MG BASE Sponsor BRISTOL-MYERS Submission history Latest submission status date: 2024-09-26 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.