APPLICATION
ANDA203044
TYPE
ANDA
ORIGINAL APPROVAL
2015-02-20
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2023-06-07Labeling · Supplement 32 · standardAP
2015-11-27Labeling · Supplement 3 · standardAP
2015-11-27Manufacturing (CMC) · Supplement 1 · unknownAP
2015-02-20UNKNOWN · 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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