APPLICATION
ANDA204319
TYPE
ANDA
ORIGINAL APPROVAL
2016-01-27
LATEST ACTION
2021-11-18
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
2021-11-18Labeling · Supplement 8 · standardAP
2021-11-18Labeling · Supplement 7 · standardAP
2021-11-18Labeling · Supplement 3 · standardAP
2021-11-18Labeling · Supplement 1 · standardAP
2016-01-27UNKNOWN · 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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