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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Moodys
US Department of Justice
Farmers Insurance
Johnson and Johnson
Baxter
Fish and Richardson
Colorcon
Chubb

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204459

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NDA 204459 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Impax Labs, Mallinckrodt Inc, Par Pharm, Sun Pharm Inds Ltd, West-ward Pharms Int, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in twelve NDAs. It is available from ten suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 204459
Tradename:OXYMORPHONE HYDROCHLORIDE
Applicant:Aurolife Pharma Llc
Ingredient:oxymorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 204459
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 204459
Suppliers and Packaging for NDA: 204459
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 204459 ANDA Aurolife Pharma, LLC 13107-103 13107-103-99 1000 TABLET in 1 BOTTLE (13107-103-99)
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 204459 ANDA Aurolife Pharma, LLC 13107-103 13107-103-01 100 TABLET in 1 BOTTLE (13107-103-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 26, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 26, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Covington
Express Scripts
Teva
Queensland Health
US Army
Citi
Novartis
Chinese Patent Office
McKesson

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