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Serving leading biopharmaceutical companies globally:

Accenture
Dow
Healthtrust
Boehringer Ingelheim
Daiichi Sankyo
Cantor Fitzgerald
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Farmers Insurance
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Generated: January 24, 2018

DrugPatentWatch Database Preview

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, Barr, Duramed Pharms Barr, Halsey, Mallinckrodt, Mutual Pharm, Vintage Pharms, Vintage Pharms Llc, Watson Labs, Mallinckrodt Inc, Alvogen Malta, Amneal Pharms, Amneal Pharms Ny, Ascent Pharms Inc, Aurolife Pharma Llc, Cerovene Inc, Lannett Holdings Inc, Mayne Pharma Inc, Mikart, Novel Labs Inc, Rhodes Pharms, and Sun Pharm Inds Inc, and is included in forty-one NDAs. It is available from forty-eight 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-three suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.
Summary for 040535
Tradename:OXYCODONE AND ACETAMINOPHEN
Applicant:Watson Labs
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
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
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040535 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-853 49999-853-30 30 TABLET in 1 BOTTLE (49999-853-30)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 040535 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-853 49999-853-60 60 TABLET in 1 BOTTLE (49999-853-60)

Profile for product number 001

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

Profile for product number 002

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

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Deloitte
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Cerilliant
Moodys

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