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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 202946


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NDA 202946 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, 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. Ten suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 202946
Tradename:OXYMORPHONE HYDROCHLORIDE
Applicant:Specgx Llc
Ingredient:oxymorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202946

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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