General MedicationsORALStandard
ALPRAZOLAM
ALPRAZOLAM
Standard Dose
0.25MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ALPRAZOLAM is listed in Drugs@FDA under application 078561 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ALPRAZOLAM Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 0.25MG Sponsor ACTAVIS ELIZABETH Submission history Latest submission status date: 2023-01-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview ALPRAZOLAM is listed in Drugs@FDA under application 078561 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ALPRAZOLAM Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 0.25MG Sponsor ACTAVIS ELIZABETH Submission history Latest submission status date: 2023-01-17 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.