APPLICATION
ANDA210022
TYPE
ANDA
ORIGINAL APPROVAL
2023-02-24
LATEST ACTION
2026-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 7.5MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 2.5MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET · ORAL
Approval history
2026-01-22Labeling · Supplement 2 · standardAP
2023-02-24UNKNOWN · Original · 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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