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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200534

OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
Active Ingredient: OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N200534
Product Number: 001
Approval Date: Oct 20, 2010
Applicant Holder Full Name: GENUS LIFE SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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