APPLICATION
ANDA202287
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-23
LATEST ACTION
2025-08-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 7.5MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 2.5MG · TABLET · ORAL
Approval history
2025-08-04Labeling · Supplement 6 · standardAP
2021-11-24Labeling · Supplement 5 · standardAP
2021-11-24Labeling · Supplement 3 · standardAP
2021-11-24Labeling · Supplement 4 · standardAP
2021-11-24Labeling · Supplement 2 · standardAP
2014-12-08Labeling · Supplement 1 · standardAP
2012-04-23OriginalAP
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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