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General MedicationsINHALATIONStandard

SPIRIVA RESPIMAT

TIOTROPIUM BROMIDE

Standard Dose
EQ 0.0025MG BASE/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SPIRIVA RESPIMAT is listed in Drugs@FDA under application 021936 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TIOTROPIUM BROMIDE Form and strength SPRAY, METERED;INHALATION - EQ 0.0025MG BASE/INH Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2024-12-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview SPIRIVA RESPIMAT is listed in Drugs@FDA under application 021936 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TIOTROPIUM BROMIDE Form and strength SPRAY, METERED;INHALATION - EQ 0.0025MG BASE/INH Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2024-12-27 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.