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US Department of Justice
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Federal Trade Commission
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US Army
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Julphar
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Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203823

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NDA 203823 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 203823

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

Pharmacology for NDA: 203823

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 203823

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 203823 ANDA Lannett Company, Inc. 0527-1774 0527-1774-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0527-1774-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Aug 1, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Baxter
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Chinese Patent Office
Deloitte
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McKesson
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