FDA ANDA · ANDA210968
OLANZAPINE
Sponsor: EUGIA PHARMA
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APPLICATION
ANDA210968
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-22
LATEST ACTION
2026-10-09
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
OLANZAPINEPrescription
OLANZAPINE 10MG/VIAL · POWDER · INTRAMUSCULAR
Approval history
2026-10-09Labeling · Supplement 6 · standardAP
2025-09-03Labeling · Supplement 4 · standardAP
2020-10-22UNKNOWN · Original · standardAP
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