General MedicationsORALStandard
ONYDA XR
CLONIDINE HYDROCHLORIDE
Standard Dose
0.1MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ONYDA XR is listed in Drugs@FDA under application 217645 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient CLONIDINE HYDROCHLORIDE Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - 0.1MG/ML Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-05-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview ONYDA XR is listed in Drugs@FDA under application 217645 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CLONIDINE HYDROCHLORIDE Form and strength SUSPENSION, EXTENDED RELEASE;ORAL - 0.1MG/ML Sponsor TRIS PHARMA INC Submission history Latest submission status date: 2025-05-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.