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FDA ANDA · ANDA213683

BREXPIPRAZOLE

Sponsor: ALEMBIC

APPLICATION
ANDA213683
TYPE
ANDA
ORIGINAL APPROVAL
2025-01-13
LATEST ACTION
2025-01-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BREXPIPRAZOLEPrescription
BREXPIPRAZOLE 1MG · TABLET · ORAL
BREXPIPRAZOLEPrescription
BREXPIPRAZOLE 0.25MG · TABLET · ORAL
BREXPIPRAZOLEPrescription
BREXPIPRAZOLE 4MG · TABLET · ORAL
BREXPIPRAZOLEPrescription
BREXPIPRAZOLE 2MG · TABLET · ORAL
BREXPIPRAZOLEPrescription
BREXPIPRAZOLE 0.5MG · TABLET · ORAL
BREXPIPRAZOLEPrescription
BREXPIPRAZOLE 3MG · TABLET · ORAL

Approval history

2025-01-13UNKNOWN · Original · standardAP
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Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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