APPLICATION
ANDA204866
TYPE
ANDA
ORIGINAL APPROVAL
2017-06-16
LATEST ACTION
2024-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OLANZAPINEDiscontinued
OLANZAPINE 15MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 7.5MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 2.5MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 20MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 10MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 5MG · TABLET · ORAL
Approval history
2024-06-18Labeling · Supplement 2 · standardAP
2024-06-18Labeling · Supplement 3 · standardAP
2024-06-18Labeling · Supplement 1 · standardAP
2017-06-16UNKNOWN · Original · 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.
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.