General MedicationsORALStandard
SPRITAM
LEVETIRACETAM
Standard Dose
250MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview SPRITAM is listed in Drugs@FDA under application 207958 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient LEVETIRACETAM Form and strength TABLET, FOR SUSPENSION;ORAL - 250MG Sponsor APRECIA PHARMS Submission history Latest submission status date: 2025-06-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview SPRITAM is listed in Drugs@FDA under application 207958 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient LEVETIRACETAM Form and strength TABLET, FOR SUSPENSION;ORAL - 250MG Sponsor APRECIA PHARMS Submission history Latest submission status date: 2025-06-27 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.