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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 088790

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NDA 088790 describes TYLOX, which is a drug marketed by Janssen Pharms and Ortho Mcneil Pharm and is included in three NDAs. Additional details are available on the TYLOX profile page.

The generic ingredient in TYLOX is acetaminophen; oxycodone hydrochloride; oxycodone terephthalate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride; oxycodone terephthalate profile page.

Summary for 088790

Tradename:	TYLOX
Applicant:	Janssen Pharms
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG;5MG
Approval Date:	Dec 12, 1984	TE:		RLD:	No

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