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Serving leading biopharmaceutical companies globally:

Teva
Fuji
Deloitte
Johnson and Johnson
Chubb
Harvard Business School
Farmers Insurance
Queensland Health
Cipla
Cerilliant

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201278

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NDA 201278 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 201278
Tradename:OXYCODONE AND ACETAMINOPHEN
Applicant:Rhodes Pharms
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201278
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 201278
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201278 ANDA Rhodes Pharmaceuticals L.P. 42858-102 42858-102-50 500 TABLET in 1 BOTTLE, PLASTIC (42858-102-50)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 201278 ANDA Rhodes Pharmaceuticals L.P. 42858-102 42858-102-01 100 TABLET in 1 BOTTLE, PLASTIC (42858-102-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Aug 28, 2014TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Aug 28, 2014TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;10MG
Approval Date:Aug 28, 2014TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Healthtrust
McKinsey
US Department of Justice
Cerilliant
Cantor Fitzgerald
Express Scripts
AstraZeneca
Farmers Insurance
Baxter

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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