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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 088246

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NDA 088246 describes TYLOX-325, which is a drug marketed by Ortho Mcneil Pharm and is included in one NDA. Additional details are available on the TYLOX-325 profile page.

The generic ingredient in TYLOX-325 is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 088246

Tradename:	TYLOX-325
Applicant:	Ortho Mcneil Pharm
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	325MG;5MG
Approval Date:	Nov 8, 1984	TE:		RLD:	No

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