General MedicationsORALStandard
HALOPERIDOL
HALOPERIDOL
Standard Dose
10MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview HALOPERIDOL is listed in Drugs@FDA under application 218789 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient HALOPERIDOL Form and strength TABLET;ORAL - 10MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-01-22 00:00:00.
Structured Monograph
Clinical summary
Approval overview HALOPERIDOL is listed in Drugs@FDA under application 218789 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient HALOPERIDOL Form and strength TABLET;ORAL - 10MG Sponsor AUROBINDO PHARMA LTD Submission history Latest submission status date: 2025-01-22 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.