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Serving leading biopharmaceutical companies globally:

Fuji
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076636

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NDA 076636 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Novel Labs Inc, Mayne Pharma Inc, West-ward Pharms Int, Wes Pharma Inc, Vintage Pharms, Alvogen Malta, Hi-tech Pharmacal, Ascent Pharms Inc, Ken Lifescience, Pharm Assoc, Lannett Holdings Inc, Lehigh Valley, Actavis Elizabeth, Vistapharm, Amneal Pharms, Ani Pharms Inc, Wockhardt Bio Ag, Mallinckrodt Inc, Sun Pharm Inds Inc, Aurolife Pharma Llc, Epic Pharma Llc, Avanthi Inc, Nesher Pharms, Rhodes Pharms, Abhai Llc, Barr Labs Inc, and Watson Labs, and is included in forty-three NDAs. It is available from forty-nine suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.

Summary for 076636

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 076636

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 076636

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL 076636 ANDA Actavis Pharma, Inc. 0228-2876 0228-2876-11 100 TABLET in 1 BOTTLE (0228-2876-11)
OXYCODONE HYDROCHLORIDE
oxycodone hydrochloride
TABLET;ORAL 076636 ANDA Actavis Pharma, Inc. 0228-2878 0228-2878-11 100 TABLET in 1 BOTTLE (0228-2878-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Feb 6, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Feb 6, 2004TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 7, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Covington
Chubb
Argus Health
Accenture
Daiichi Sankyo
Dow
Chinese Patent Office
Federal Trade Commission
Queensland Health

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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