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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 201448

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NDA 201448 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-five suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 201448

Tradename:	OXYCODONE AND ACETAMINOPHEN
Applicant:	Sankalp Lifecare
Ingredient:	acetaminophen; oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 201448

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 201448

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	SOLUTION;ORAL	201448	ANDA	Nostrum Laboratories, Inc.	29033-405	29033-405-35	500 mL in 1 BOTTLE (29033-405-35)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	325MG/5ML;5MG/5ML
Approval Date:	Aug 26, 2021	TE:		RLD:	No

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