General MedicationsORALStandard
HYDREA
HYDROXYUREA
Standard Dose
500MG
Max Dose
Refer to approved labeling
Primary Use
Medication Guide is for DROXIA. Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview HYDREA is listed in Drugs@FDA under application 016295 (NDA).
Medication Guide is for DROXIA.
Structured Monograph
Clinical summary
Approval overview HYDREA is listed in Drugs@FDA under application 016295 (NDA). Medication Guide is for DROXIA. Review priority: STANDARD Marketing status: Prescription Active ingredient HYDROXYUREA Form and strength CAPSULE;ORAL - 500MG Sponsor WAYLIS THERAP Submission history Latest submission status date: 2024-06-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.