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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 201448

OXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG/5ML;5MG/5ML
Marketing Status: Prescription
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: OXYCODONE AND ACETAMINOPHEN
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 325MG/5ML;5MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A201448
Product Number: 001
Approval Date: Aug 26, 2021
Applicant Holder Full Name: NOSTRUM LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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