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FDA ANDA · ANDA201588

OLANZAPINE

Sponsor: SANDOZ INC

APPLICATION
ANDA201588
TYPE
ANDA
ORIGINAL APPROVAL
2011-10-24
LATEST ACTION
2024-05-29
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

OLANZAPINEPrescription
OLANZAPINE 10MG/VIAL · POWDER · INTRAMUSCULAR

Approval history

2024-05-29Labeling · Supplement 6 · standardAP
2024-05-29Labeling · Supplement 11 · standardAP
2024-05-29Labeling · Supplement 9 · standardAP
2024-05-29Labeling · Supplement 3 · standardAP
2024-05-29Labeling · Supplement 10 · standardAP
2011-10-24Not Applicable · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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