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Serving leading biopharmaceutical companies globally:

Merck
Daiichi Sankyo
Argus Health
Covington
Accenture
Boehringer Ingelheim
Moodys
QuintilesIMS
Queensland Health
Fish and Richardson

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204085

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NDA 204085 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Lannett Holdings Inc, Lehigh Valley, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Ken Lifescience, Mallinckrodt Inc, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-four NDAs. It is available from forty-eight 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 204085
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Lannett Holdings Inc
Ingredient:oxycodone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204085
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 204085
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204085 ANDA Lannett Company, Inc. 0527-1426 0527-1426-35 1 BOTTLE, PLASTIC in 1 CARTON (0527-1426-35) > 15 mL in 1 BOTTLE, PLASTIC
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204085 ANDA Lannett Company, Inc. 0527-1426 0527-1426-36 1 BOTTLE, PLASTIC in 1 CARTON (0527-1426-36) > 30 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Sep 9, 2014TE:AARLD:No

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Serving leading biopharmaceutical companies globally:

Dow
Chinese Patent Office
Colorcon
Baxter
Daiichi Sankyo
Mallinckrodt
Harvard Business School
Deloitte
Federal Trade Commission

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