General MedicationsORALStandard
ONTRALFY
TIZANIDINE HYDROCHLORIDE
Standard Dose
EQ 2MG BASE/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ONTRALFY is listed in Drugs@FDA under application 216190 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TIZANIDINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - EQ 2MG BASE/5ML Sponsor FIDELITY BIOPHARMA Submission history Latest submission status date: 2024-12-12 00:00:00.
Structured Monograph
Clinical summary
Approval overview ONTRALFY is listed in Drugs@FDA under application 216190 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TIZANIDINE HYDROCHLORIDE Form and strength SOLUTION;ORAL - EQ 2MG BASE/5ML Sponsor FIDELITY BIOPHARMA Submission history Latest submission status date: 2024-12-12 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.