APPLICATION
ANDA091415
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-25
LATEST ACTION
2025-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-12-03Labeling · Supplement 17 · standardAP
2022-07-08Labeling · Supplement 11 · standardAP
2022-07-08Labeling · Supplement 7 · standardAP
2022-07-08Labeling · Supplement 14 · standardAP
2022-07-08Labeling · Supplement 10 · standardAP
2022-07-08Labeling · Supplement 6 · standardAP
2022-07-08Labeling · Supplement 13 · standardAP
2015-01-17Labeling · Supplement 4 · standardAP
2011-10-25OriginalAP
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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