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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 211708


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NDA 211708 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, Cerovene Inc, Chartwell, Dr Reddys Labs Sa, Epic Pharma Llc, Granules, Lannett Co Inc, Nesher Pharms, Novel Labs Inc, Rhodes Pharms, Sun Pharm Inds Inc, and Wes Pharma Inc, and is included in fifty-one NDAs. It is available from thirty-three 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 211708
Pharmacology for NDA: 211708
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 211708
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 211708 ANDA Granules Pharmaceuticals Inc. 70010-667 70010-667-01 100 TABLET in 1 BOTTLE (70010-667-01)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 211708 ANDA Granules Pharmaceuticals Inc. 70010-667 70010-667-05 500 TABLET in 1 BOTTLE (70010-667-05)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;2.5MG
Approval Date:Oct 31, 2019TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Oct 31, 2019TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Oct 31, 2019TE:RLD:No

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