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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 201278

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NDA 201278 describes OXYCODONE AND ACETAMINOPHEN, which is a drug marketed by Actavis Elizabeth, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Abhai Llc, Mikart, Sankalp Lifecare, Specgx Llc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Ph Health, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in fifty-one NDAs. It is available from thirty-two suppliers. Additional details are available on the OXYCODONE AND ACETAMINOPHEN profile page.

The generic ingredient in OXYCODONE AND ACETAMINOPHEN 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 201278

Tradename:	OXYCODONE AND ACETAMINOPHEN
Applicant:	Rhodes Pharms
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 201278

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 201278

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	201278	ANDA	Rhodes Pharmaceuticals L.P.	42858-102	42858-102-01	100 TABLET in 1 BOTTLE, PLASTIC (42858-102-01)
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	201278	ANDA	Rhodes Pharmaceuticals L.P.	42858-102	42858-102-10	10 BLISTER PACK in 1 CARTON (42858-102-10) / 10 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;5MG
Approval Date:	Aug 28, 2014	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;7.5MG
Approval Date:	Aug 28, 2014	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;10MG
Approval Date:	Aug 28, 2014	TE:	AA	RLD:	No

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