General MedicationsORALStandard
JAVADIN
CLONIDINE HYDROCHLORIDE
Standard Dose
0.02MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview JAVADIN is listed in Drugs@FDA under application 220256 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient CLONIDINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 0.02MG/ML Sponsor AZURITY Submission history Latest submission status date: 2025-10-23 00:00:00.
Structured Monograph
Clinical summary
Approval overview JAVADIN is listed in Drugs@FDA under application 220256 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CLONIDINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - 0.02MG/ML Sponsor AZURITY Submission history Latest submission status date: 2025-10-23 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.