General MedicationsINTRATHECALStandard
PRIALT
ZICONOTIDE ACETATE
Standard Dose
500MCG/5ML (100MCG/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview PRIALT is listed in Drugs@FDA under application 021060 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ZICONOTIDE ACETATE Form and strength INJECTABLE;INTRATHECAL - 500MCG/5ML (100MCG/ML) Sponsor TERSERA Submission history Latest submission status date: 2023-03-16 00:00:00.
Structured Monograph
Clinical summary
Approval overview PRIALT is listed in Drugs@FDA under application 021060 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ZICONOTIDE ACETATE Form and strength INJECTABLE;INTRATHECAL - 500MCG/5ML (100MCG/ML) Sponsor TERSERA Submission history Latest submission status date: 2023-03-16 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.