APPLICATION
ANDA202862
TYPE
ANDA
ORIGINAL APPROVAL
2014-08-15
LATEST ACTION
2026-01-06
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
2026-01-06Labeling · Supplement 53 · standardAP
2023-06-07Labeling · Supplement 37 · standardAP
2023-06-07Labeling · Supplement 34 · standardAP
2021-11-19Labeling · Supplement 10 · standardAP
2021-11-19Labeling · Supplement 25 · standardAP
2021-11-19Labeling · Supplement 11 · standardAP
2021-11-19Labeling · Supplement 26 · standardAP
2021-11-19Labeling · Supplement 18 · standardAP
2015-11-05Labeling · Supplement 5 · standardAP
2015-11-05Manufacturing (CMC) · Supplement 3 · unknownAP
2015-11-05Labeling · Supplement 1 · standardAP
2014-08-15UNKNOWN · 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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