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Serving leading biopharmaceutical companies globally:

Accenture
Cipla
Harvard Business School
McKinsey
Express Scripts
Farmers Insurance
Teva
US Army
Covington
Chinese Patent Office

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090535

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NDA 090535 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 090535
Tradename:OXYCODONE AND ACETAMINOPHEN
Applicant:Sun Pharm Inds Inc
Ingredient:acetaminophen; oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090535
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 090535
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090535 ANDA Sun Pharmaceutical Industries, Inc. 57664-155 57664-155-88 100 TABLET in 1 BOTTLE (57664-155-88)
OXYCODONE AND ACETAMINOPHEN acetaminophen; oxycodone hydrochloride TABLET;ORAL 090535 ANDA Sun Pharmaceutical Industries, Inc. 57664-155 57664-155-13 500 TABLET in 1 BOTTLE (57664-155-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;2.5MG
Approval Date:Dec 26, 2013TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;5MG
Approval Date:Dec 26, 2013TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength325MG;7.5MG
Approval Date:Dec 26, 2013TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

McKinsey
Deloitte
Medtronic
Healthtrust
Farmers Insurance
Mallinckrodt
Cerilliant
Daiichi Sankyo
Dow

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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