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Generated: July 23, 2017

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 Avanthi Inc, Sun Pharm Inds Ltd, Mallinckrodt Inc, West-ward Pharms Int, Teva, Actavis Elizabeth, Aurolife Pharma Llc, Impax Labs, Epic Pharma Llc, and Par Pharm, and is included in twelve NDAs. It is available from eleven 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. Twenty suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for NDA: 204459

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

Pharmacology for NDA: 204459

Mechanism of ActionFull Opioid Agonists

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 13107-103-01 100 TABLET in 1 BOTTLE (13107-103-01)
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET;ORAL 204459 ANDA Aurolife Pharma, LLC 13107-103 13107-103-30 30 TABLET in 1 BOTTLE (13107-103-30)

Summary for product number 001

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

Summary for product number 002

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


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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Daiichi Sankyo
Fuji
UBS
Cipla
McKesson
Covington
Healthtrust
Harvard Business School
Chubb

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