APPLICATION
ANDA076133
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-24
LATEST ACTION
2026-02-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET · ORAL
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET · ORAL
Approval history
2026-02-09Labeling · Supplement 20 · standardAP
2023-02-09Labeling · Supplement 16 · standardAP
2020-11-09Labeling · Supplement 11 · standardAP
2020-11-09Labeling · Supplement 5 · standardAP
2020-11-09Labeling · Supplement 8 · standardAP
2020-11-09Labeling · Supplement 10 · standardAP
2020-11-09Labeling · Supplement 6 · standardAP
2020-11-09Labeling · Supplement 4 · standardAP
2014-12-20Labeling · Supplement 2 · standardAP
2014-12-20Labeling · Supplement 3 · standardAP
2012-04-23OriginalAP
2011-10-24OriginalAP
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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