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Serving leading biopharmaceutical companies globally:

Medtronic
UBS
Chinese Patent Office
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Accenture
US Army
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Harvard Business School

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202946

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NDA 202946 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 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. Nineteen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for 202946

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

Pharmacology for NDA: 202946

Mechanism of ActionFull Opioid Agonists

Medical Subject Heading (MeSH) Categories for 202946

Suppliers and Packaging for NDA: 202946

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202946 ANDA Mallinckrodt, Inc. 0406-8091 0406-8091-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-8091-01)
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 202946 ANDA Mallinckrodt, Inc. 0406-8092 0406-8092-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0406-8092-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Jun 27, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength7.5MG
Approval Date:Jun 27, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Jun 27, 2014TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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