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Last Updated: November 18, 2024

Details for New Drug Application (NDA): 040255

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NDA 040255 describes OXYCODONE AND ASPIRIN, which is a drug marketed by Actavis Labs Fl Inc, Ani Pharms, Dr Reddys Labs Sa, Epic Pharma Llc, Sun Pharm Industries, and Roxane, and is included in seven NDAs. It is available from one supplier. Additional details are available on the OXYCODONE AND ASPIRIN profile page.

The generic ingredient in OXYCODONE AND ASPIRIN is aspirin; oxycodone hydrochloride; oxycodone terephthalate. There are twenty-two drug master file entries for this compound. Additional details are available on the aspirin; oxycodone hydrochloride; oxycodone terephthalate profile page.

Summary for 040255

Tradename:	OXYCODONE AND ASPIRIN
Applicant:	Ani Pharms
Ingredient:	aspirin; oxycodone hydrochloride; oxycodone terephthalate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	325MG;4.5MG;0.38MG
Approval Date:	Feb 27, 1998	TE:		RLD:	No

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