General MedicationsINJECTIONStandard
ORAVERSE
PHENTOLAMINE MESYLATE
Standard Dose
0.4MG/1.7ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ORAVERSE is listed in Drugs@FDA under application 022159 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient PHENTOLAMINE MESYLATE Form and strength INJECTABLE;INJECTION - 0.4MG/1.7ML Sponsor SEPTODONT HOLDING Submission history Latest submission status date: 2016-03-18 00:00:00.
Structured Monograph
Clinical summary
Approval overview ORAVERSE is listed in Drugs@FDA under application 022159 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PHENTOLAMINE MESYLATE Form and strength INJECTABLE;INJECTION - 0.4MG/1.7ML Sponsor SEPTODONT HOLDING Submission history Latest submission status date: 2016-03-18 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.