APPLICATION
ANDA078109
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-24
LATEST ACTION
2026-01-06
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2026-01-06Labeling · Supplement 19 · standardAP
2023-06-13Labeling · Supplement 13 · standardAP
2021-08-26Labeling · Supplement 8 · standardAP
2021-08-26Labeling · Supplement 7 · standardAP
2021-08-26Labeling · Supplement 5 · 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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