APPLICATION
ANDA200221
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-12
LATEST ACTION
2020-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2020-09-15Labeling · Supplement 16 · standardAP
2020-09-15Labeling · Supplement 9 · standardAP
2020-09-15Labeling · Supplement 7 · standardAP
2020-09-15Labeling · Supplement 8 · standardAP
2014-12-08Labeling · Supplement 4 · standardAP
2013-11-07Labeling · Supplement 1 · standardAP
2012-09-12Not Applicable · 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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