FDA NDA · NDA219007

WELTRUZA

Sponsor: TEVA NEUROSCIENCE INC

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APPLICATION
NDA219007
TYPE
NDA
ORIGINAL APPROVAL
2026-10-08
LATEST ACTION
2026-10-08
ROUTE
INJECTABLE
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

WELTRUZAPrescription
OLANZAPINE 531MG · SUSPENSION, EXTENDED RELEASE · INJECTABLE
WELTRUZAPrescription
OLANZAPINE 318MG · SUSPENSION, EXTENDED RELEASE · INJECTABLE
WELTRUZAPrescription
OLANZAPINE 425MG · SUSPENSION, EXTENDED RELEASE · INJECTABLE

Approval history

2026-10-08Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP