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Cantor Fitzgerald
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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090964

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NDA 090964 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, West-ward Pharms Int, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in thirteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 090964
Tradename:OXYMORPHONE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:oxymorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 090964
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 090964
Suppliers and Packaging for NDA: 090964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 090964 ANDA West-Ward Pharmaceuticals Corp. 0054-0283 N 0054-0283-25
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 090964 ANDA West-Ward Pharmaceuticals Corp. 0054-0284 N 0054-0284-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Sep 27, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 27, 2010TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
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Cipla
Accenture
Boehringer Ingelheim
Argus Health
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