FDA ANDA · ANDA201588

OLANZAPINE

Sponsor: SANDOZ INC

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APPLICATION
ANDA201588
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-24
LATEST ACTION
2026-10-01
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

OLANZAPINEPrescription
OLANZAPINE 10MG/VIAL · POWDER · INTRAMUSCULAR

Approval history

2026-10-01Labeling · Supplement 17 · standardAP
2026-10-01Labeling · Supplement 18 · standardAP
2024-05-29Labeling · Supplement 6 · standardAP
2024-05-29Labeling · Supplement 11 · standardAP
2024-05-29Labeling · Supplement 9 · standardAP
2024-05-29Labeling · Supplement 3 · standardAP
2024-05-29Labeling · Supplement 10 · standardAP
2011-10-24Not Applicable · Original — Letter ↗AP