General MedicationsORALStandard
ERMEZA
LEVOTHYROXINE SODIUM
Standard Dose
150MCG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ERMEZA is listed in Drugs@FDA under application 215809 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LEVOTHYROXINE SODIUM Form and strength SOLUTION;ORAL - 150MCG/5ML Sponsor MYLAN Submission history Latest submission status date: 2022-04-29 00:00:00.
Structured Monograph
Clinical summary
Approval overview ERMEZA is listed in Drugs@FDA under application 215809 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEVOTHYROXINE SODIUM Form and strength SOLUTION;ORAL - 150MCG/5ML Sponsor MYLAN Submission history Latest submission status date: 2022-04-29 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.