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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 209385

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NDA 209385 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 twenty-eight 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-one suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 209385

Tradename:	OXYCODONE AND ACETAMINOPHEN
Applicant:	Elite Labs Inc
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 209385

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 209385

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	209385	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-964	60760-964-30	30 TABLET in 1 BOTTLE, PLASTIC (60760-964-30)
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	209385	ANDA	ST. MARY'S MEDICAL PARK PHARMACY	60760-964	60760-964-60	60 TABLET in 1 BOTTLE, PLASTIC (60760-964-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;5MG
Approval Date:	Jul 2, 2018	TE:	AA	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;7.5MG
Approval Date:	Jul 2, 2018	TE:	AA	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	325MG;10MG
Approval Date:	Jul 2, 2018	TE:	AA	RLD:	No

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