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Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203506

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NDA 203506 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 203506
Tradename:OXYMORPHONE HYDROCHLORIDE
Applicant:Sun Pharm Inds Ltd
Ingredient:oxymorphone hydrochloride
Patents:0
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203506
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 203506
Suppliers and Packaging for NDA: 203506
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 203506 ANDA Ranbaxy Pharmaceuticals Inc. 63304-218 N 63304-218-05
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 203506 ANDA Ranbaxy Pharmaceuticals Inc. 63304-218 N 63304-218-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Apr 24, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength7.5MG
Approval Date:Apr 24, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Apr 24, 2015TE:ABRLD:No

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