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Details for New Drug Application (NDA): 040535

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NDA 040535 describes OXYCODONE AND ACETAMINOPHEN, which is a drug marketed by Actavis Elizabeth, Vintage Pharms Llc, Barr, Vintage Pharms, Mikart, Mutual Pharm, Watson Labs, Sun Pharm Inds Inc, Mallinckrodt, Aurolife Pharma Llc, Duramed Pharms Barr, Alvogen Malta, Amneal Pharms Ny, Mayne Pharma Inc, Rhodes Pharms, Mallinckrodt Inc, and Halsey, and is included in thirty-seven NDAs. It is available from thirty-six 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-five drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for NDA: 040535

Pharmacology for NDA: 040535

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 040535

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 040535 ANDA PD-Rx Pharmaceuticals, Inc. 43063-231 43063-231-20 20 TABLET in 1 BOTTLE, PLASTIC (43063-231-20)
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 040535 ANDA PD-Rx Pharmaceuticals, Inc. 43063-231 43063-231-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-231-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Sep 5, 2003TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Sep 5, 2003TE:AARLD:No

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