APPLICATION
ANDA091434
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-23
LATEST ACTION
2025-12-02
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
2025-12-02Labeling · Supplement 19 · standardAP
2022-07-13Labeling · Supplement 15 · standardAP
2022-07-13Labeling · Supplement 13 · standardAP
2022-07-13Labeling · Supplement 16 · standardAP
2022-07-13Labeling · Supplement 12 · standardAP
2022-07-13Labeling · Supplement 10 · standardAP
2022-07-13Labeling · Supplement 9 · standardAP
2014-12-08Labeling · Supplement 8 · 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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