APPLICATION
ANDA076866
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-23
LATEST ACTION
2023-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
OLANZAPINEDiscontinued
OLANZAPINE 20MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 10MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 5MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 15MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 7.5MG · TABLET · ORAL
OLANZAPINEDiscontinued
OLANZAPINE 2.5MG · TABLET · ORAL
Approval history
2023-08-08Labeling · Supplement 9 · standardAP
2023-08-08Labeling · Supplement 7 · standardAP
2023-08-08Labeling · Supplement 5 · standardAP
2023-08-08Labeling · Supplement 6 · standardAP
2015-09-25Labeling · Supplement 3 · standardAP
2015-09-25Labeling · Supplement 4 · standardAP
2012-04-23OriginalAP
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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