General MedicationsINHALATIONStandard
SPIRIVA RESPIMAT
TIOTROPIUM BROMIDE
Standard Dose
2.5MCG
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 207070 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TIOTROPIUM BROMIDE Form and strength SPRAY;INHALATION - 2.5MCG Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2015-09-15 00:00:00.
Structured Monograph
Clinical summary
Approval overview SPIRIVA RESPIMAT is listed in Drugs@FDA under application 207070 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TIOTROPIUM BROMIDE Form and strength SPRAY;INHALATION - 2.5MCG Sponsor BOEHRINGER INGELHEIM Submission history Latest submission status date: 2015-09-15 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.