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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cerilliant
Merck
Mallinckrodt
Federal Trade Commission
Fish and Richardson
UBS
McKinsey
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Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202116

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NDA 202116 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Specgx Llc, 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, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in forty-five 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 202116
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Alvogen Malta
Ingredient:oxycodone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 202116
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 202116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 202116 ANDA Alvogen, Inc. 47781-263 N 47781-263-01
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 202116 ANDA Alvogen, Inc. 47781-263 N 47781-263-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 30, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Dec 30, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Dec 30, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
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Chinese Patent Office
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Queensland Health
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