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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 200535

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OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
5MG/5ML
Marketing Status: Prescription
Active Ingredient: OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AA
Application Number: N200535
Product Number: 002
Approval Date: Aug 22, 2013
Applicant Holder Full Name: GENUS LIFE SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
100MG/5ML
Marketing Status: Prescription
Active Ingredient: OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 100MG/5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N200535
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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