APPLICATION
ANDA090798
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-23
LATEST ACTION
2023-06-13
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
2023-06-13Labeling · Supplement 18 · standardAP
2023-06-13Labeling · Supplement 14 · standardAP
2023-06-13Labeling · Supplement 12 · standardAP
2023-06-13Labeling · Supplement 10 · standardAP
2023-06-13Labeling · Supplement 6 · standardAP
2023-06-13Labeling · Supplement 4 · 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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