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Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203601

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NDA 203601 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 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. Sixteen suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 203601
Applicant:Avanthi Inc
Ingredient:oxymorphone hydrochloride
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203601
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 203601
Suppliers and Packaging for NDA: 203601
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 203601 ANDA KVK-Tech, Inc. 10702-070 N 10702-070-01
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 203601 ANDA KVK-Tech, Inc. 10702-071 N 10702-071-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 30, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 30, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Argus Health

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