General MedicationsORALGeneric
BREXPIPRAZOLE
BREXPIPRAZOLE
Standard Dose
0.5MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary
Approval overview BREXPIPRAZOLE is listed in Drugs@FDA under application 213782 (ANDA).
Review priority: STANDARD Marketing status: Discontinued Active ingredient BREXPIPRAZOLE Form and strength TABLET;ORAL - 0.5MG Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2023-11-28 00:00:00.
Structured Monograph
Clinical summary
Approval overview BREXPIPRAZOLE is listed in Drugs@FDA under application 213782 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient BREXPIPRAZOLE Form and strength TABLET;ORAL - 0.5MG Sponsor ALKEM LABS LTD Submission history Latest submission status date: 2023-11-28 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Discontinued
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.