APPLICATION
ANDA090881
TYPE
ANDA
ORIGINAL APPROVAL
2012-02-28
LATEST ACTION
2021-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued
Products
OLANZAPINEDiscontinued
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2021-06-17Labeling · Supplement 8 · standardAP
2015-10-19Labeling · Supplement 4 · standardAP
2015-10-19Labeling · Supplement 5 · standardAP
2015-10-19Labeling · Supplement 3 · standardAP
2012-02-28OriginalAP
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.