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Last Updated: September 19, 2020

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Details for New Drug Application (NDA): 040778

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NDA 040778 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 Inc, Specgx Llc, Alvogen, Amneal Pharms, Amneal Pharms Ny, Anda Repository, Ascent Pharms Inc, Aurolife Pharma Llc, Epic Pharma Llc, Granules Pharms, Lannett Co Inc, Mayne Pharma Inc, Mikart, Nesher Pharms, Nostrum Labs Inc, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, Wes Pharma Inc, and Xiromed, and is included in fifty NDAs. It is available from thirty-four 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-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 040778
Pharmacology for NDA: 040778
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 040778
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040778 ANDA AvPAK 50268-645 50268-645-15 50 BLISTER PACK in 1 BOX (50268-645-15) > 1 TABLET in 1 BLISTER PACK (50268-645-11)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040778 ANDA AvPAK 50268-646 50268-646-15 50 BLISTER PACK in 1 BOX (50268-646-15) > 1 TABLET in 1 BLISTER PACK (50268-646-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Nov 27, 2007TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Jun 27, 2014TE:AARLD:No

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