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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079046

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NDA 079046 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: 079046

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

Pharmacology for NDA: 079046

Mechanism of ActionFull Opioid Agonists

Suppliers and Packaging for NDA: 079046

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079046 ANDA Actavis Pharma, Inc. 0228-3227 0228-3227-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3227-06)
OXYMORPHONE HYDROCHLORIDE
oxymorphone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 079046 ANDA Actavis Pharma, Inc. 0228-3227 0228-3227-11 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3227-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength7.5MG
Approval Date:Dec 13, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Dec 13, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Jul 11, 2013TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Cipla
Dow
US Department of Justice
Fuji
US Army
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Cerilliant
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Baxter

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