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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Covington
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Citi
Medtronic
Baxter
Dow
US Army

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204603

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NDA 204603 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-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 204603

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

Pharmacology for NDA: 204603

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 204603

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204603 ANDA Novel Laboratories, Inc. 40032-920 40032-920-60 1 BOTTLE in 1 CARTON (40032-920-60) > 30 mL in 1 BOTTLE
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride SOLUTION;ORAL 204603 ANDA GAVIS Pharmaceuticals, LLC 43386-920 43386-920-60 1 BOTTLE in 1 CARTON (43386-920-60) > 30 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/5ML
Approval Date:Apr 29, 2015TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
US Department of Justice
Chubb
Mallinckrodt
AstraZeneca
Chinese Patent Office
Argus Health
Merck
Julphar

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