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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 040608

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NDA 040608 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, Nostrum Labs Inc, Specgx Llc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell, Dr Reddys Labs Sa, Elite Labs Inc, Endo Operations, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sanaluz, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in fifty-one NDAs. It is available from thirty-five 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-six suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for 040608

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

Pharmacology for NDA: 040608

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 040608

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040608	ANDA	Forte Bio-Pharma LLC	72245-193	72245-193-03	30 TABLET in 1 BOTTLE, PLASTIC (72245-193-03)
OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	040608	ANDA	Forte Bio-Pharma LLC	72245-193	72245-193-10	100 TABLET in 1 BOTTLE, PLASTIC (72245-193-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;2.5MG
Approval Date:	Dec 30, 2005	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;5MG
Approval Date:	Dec 30, 2005	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG;7.5MG
Approval Date:	Dec 30, 2005	TE:		RLD:	No

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