APPLICATION
ANDA213562
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-31
LATEST ACTION
2026-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BREXPIPRAZOLEDiscontinued
BREXPIPRAZOLE 3MG · TABLET · ORAL
BREXPIPRAZOLEDiscontinued
BREXPIPRAZOLE 1MG · TABLET · ORAL
BREXPIPRAZOLEDiscontinued
BREXPIPRAZOLE 0.25MG · TABLET · ORAL
BREXPIPRAZOLEDiscontinued
BREXPIPRAZOLE 4MG · TABLET · ORAL
BREXPIPRAZOLEDiscontinued
BREXPIPRAZOLE 2MG · TABLET · ORAL
BREXPIPRAZOLEDiscontinued
BREXPIPRAZOLE 0.5MG · TABLET · ORAL
Approval history
2026-04-01Labeling · Supplement 7 · standardAP
2026-04-01Labeling · Supplement 5 · standardAP
2026-04-01Labeling · Supplement 3 · standardAP
2026-04-01Labeling · Supplement 8 · standardAP
2026-04-01Labeling · Supplement 2 · standardAP
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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