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Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040545

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NDA 040545 describes OXYCODONE AND ACETAMINOPHEN, which is a drug marketed by Actavis Elizabeth, Vintage Pharms Llc, Barr, Vintage Pharms, Novel Labs Inc, Mikart, Mutual Pharm, Ascent Pharms Inc, Watson Labs, Sun Pharm Inds Inc, Mallinckrodt, Aurolife Pharma Llc, Duramed Pharms Barr, Cerovene Inc, Alvogen Malta, Amneal Pharms, Mayne Pharma Inc, Amneal Pharms Ny, Rhodes Pharms, Mallinckrodt Inc, and Halsey, and is included in forty NDAs. It is available from forty-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. Fifty suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for NDA: 040545

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040545

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 040545

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 040545 ANDA Mallinckrodt, Inc. 0406-0522 0406-0522-01 100 TABLET in 1 BOTTLE (0406-0522-01)
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 040545 ANDA Mallinckrodt, Inc. 0406-0522 0406-0522-05 500 TABLET in 1 BOTTLE (0406-0522-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Jun 30, 2004TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Jun 30, 2004TE:AARLD:No


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