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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 201972


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NDA 201972 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 201972
Pharmacology for NDA: 201972
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 201972
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201972 ANDA Aurolife Pharma, LLC 13107-043 13107-043-01 100 TABLET in 1 BOTTLE (13107-043-01)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201972 ANDA Aurolife Pharma, LLC 13107-043 13107-043-05 500 TABLET in 1 BOTTLE (13107-043-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;2.5MG
Approval Date:Jul 15, 2013TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Jul 15, 2013TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Jul 15, 2013TE:AARLD:No

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