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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201447

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NDA 201447 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: 201447

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

Pharmacology for NDA: 201447

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 201447

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 201447 ANDA Actavis Pharma, Inc. 0228-2980 0228-2980-11 100 TABLET in 1 BOTTLE (0228-2980-11)
OXYCODONE AND ACETAMINOPHEN
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 201447 ANDA Actavis Pharma, Inc. 0228-2981 0228-2981-11 100 TABLET in 1 BOTTLE (0228-2981-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;2.5MG
Approval Date:Apr 12, 2013TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Apr 12, 2013TE:AARLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Apr 12, 2013TE:AARLD:No


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