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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 089351

ROXICET (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE)
325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Proprietary Name: ROXICET
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A089351
Product Number: 001
Approval Date: Dec 3, 1986
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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