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Details for New Drug Application (NDA): 200792

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NDA 200792 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Avanthi Inc, Sun Pharm Inds Ltd, Mallinckrodt Inc, Roxane, Teva, Actavis Elizabeth, Aurolife Pharma Llc, Impax Labs, Corepharma, and Par Pharm, 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. Twenty suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for NDA: 200792

Par Pharm
oxymorphone hydrochloride
Therapeutic Class:Analgesics

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Oct 24, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength7.5MG
Approval Date:Oct 24, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Oct 24, 2014TE:ABRLD:No

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