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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 217466

OLANZAPINE (OLANZAPINE)
10MG/VIAL
Marketing Status: Prescription
Active Ingredient: OLANZAPINE
Proprietary Name: OLANZAPINE
Dosage Form; Route of Administration: INJECTABLE; INTRAMUSCULAR
Strength: 10MG/VIAL
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A217466
Product Number: 001
Approval Date: Mar 22, 2023
Applicant Holder Full Name: ASPIRO PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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