General MedicationsINHALATIONStandard
XOPENEX HFA
LEVALBUTEROL TARTRATE
Standard Dose
EQ 0.045MG BASE/INH
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview XOPENEX HFA is listed in Drugs@FDA under application 021730 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LEVALBUTEROL TARTRATE Form and strength AEROSOL, METERED;INHALATION - EQ 0.045MG BASE/INH Sponsor LUPIN Submission history Latest submission status date: 2017-02-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview XOPENEX HFA is listed in Drugs@FDA under application 021730 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEVALBUTEROL TARTRATE Form and strength AEROSOL, METERED;INHALATION - EQ 0.045MG BASE/INH Sponsor LUPIN Submission history Latest submission status date: 2017-02-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.