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Last Updated: September 22, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202142

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NDA 202142 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 202142
Pharmacology for NDA: 202142
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 202142
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride SOLUTION;ORAL 202142 ANDA Mikart, LLC 46672-648 46672-648-04 120 mL in 1 BOTTLE, PLASTIC (46672-648-04)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride SOLUTION;ORAL 202142 ANDA Mikart, LLC 46672-648 46672-648-55 500 mL in 1 BOTTLE, PLASTIC (46672-648-55)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength300MG/5ML;10MG/5ML
Approval Date:Nov 27, 2018TE:RLD:No

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