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Generated: October 17, 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, Lannett Holdings 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-one NDAs. It is available from forty-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-six drug master file entries for this compound. Fifty-one 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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