General MedicationsORALStandard
RECORLEV
LEVOKETOCONAZOLE
Standard Dose
150MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview RECORLEV is listed in Drugs@FDA under application 214133 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LEVOKETOCONAZOLE Form and strength TABLET;ORAL - 150MG Sponsor STRONGBRIDGE Submission history Latest submission status date: 2023-08-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview RECORLEV is listed in Drugs@FDA under application 214133 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEVOKETOCONAZOLE Form and strength TABLET;ORAL - 150MG Sponsor STRONGBRIDGE Submission history Latest submission status date: 2023-08-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.