APPLICATION
ANDA091265
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-24
LATEST ACTION
2022-07-08
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
2022-07-08Labeling · Supplement 6 · standardAP
2022-07-08Labeling · Supplement 12 · standardAP
2022-07-08Labeling · Supplement 10 · standardAP
2022-07-08Labeling · Supplement 3 · standardAP
2022-07-08Labeling · Supplement 15 · standardAP
2022-07-08Labeling · Supplement 13 · standardAP
2013-08-28Labeling · Supplement 1 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.