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Serving 500+ biopharmaceutical companies globally:

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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040105

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NDA 040105 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-four 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-nine suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

Summary for NDA: 040105

Formulation / Manufacturing:see details

Pharmacology for NDA: 040105

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 040105

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 040105 ANDA Par Pharmaceutical 0603-4998 0603-4998-21 100 TABLET in 1 BOTTLE, PLASTIC (0603-4998-21)
acetaminophen; oxycodone hydrochloride
TABLET;ORAL 040105 ANDA Par Pharmaceutical 0603-4998 0603-4998-28 500 TABLET in 1 BOTTLE, PLASTIC (0603-4998-28)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Jul 30, 1996TE:AARLD:No

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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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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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