APPLICATION
ANDA203456
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-16
LATEST ACTION
2025-10-02
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
2025-10-02Labeling · Supplement 5 · standardAP
2025-10-02Labeling · Supplement 2 · standardAP
2016-03-16UNKNOWN · OriginalAP
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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