APPLICATION
ANDA201741
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-20
LATEST ACTION
2024-06-26
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 10MG/VIAL · POWDER · INTRAMUSCULAR
Approval history
2024-06-26Labeling · Supplement 2 · standardAP
2024-06-26Labeling · Supplement 7 · standardAP
2024-06-26Labeling · Supplement 5 · standardAP
2024-06-26Labeling · Supplement 4 · standardAP
2012-03-20Labeling · Supplement 11AP
2012-03-20Not 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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