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General MedicationsINHALATIONStandard

STIOLTO RESPIMAT

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

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

Approval overview STIOLTO RESPIMAT is listed in Drugs@FDA under application 206756 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE Form and strength SPRAY, METERED;INHALATION - EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2024-12-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview STIOLTO RESPIMAT is listed in Drugs@FDA under application 206756 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE Form and strength SPRAY, METERED;INHALATION - EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2024-12-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.
STIOLTO RESPIMAT (OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE) | Drug Monograph | MedicHelpline