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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 085375

TYLOX (ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE)
500MG;4.5MG;0.38MG
Marketing Status: Discontinued
Active Ingredient: ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
Proprietary Name: TYLOX
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG;4.5MG;0.38MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A085375
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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