APPLICATION
ANDA213587
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
BREXPIPRAZOLENone (Tentative Approval)
BREXPIPRAZOLE 4MG · TABLET · ORAL
BREXPIPRAZOLENone (Tentative Approval)
BREXPIPRAZOLE 2MG · TABLET · ORAL
BREXPIPRAZOLENone (Tentative Approval)
BREXPIPRAZOLE 0.5MG · TABLET · ORAL
BREXPIPRAZOLENone (Tentative Approval)
BREXPIPRAZOLE 3MG · TABLET · ORAL
BREXPIPRAZOLENone (Tentative Approval)
BREXPIPRAZOLE 1MG · TABLET · ORAL
BREXPIPRAZOLENone (Tentative Approval)
BREXPIPRAZOLE 0.25MG · TABLET · ORAL
Approval history
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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