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Last Updated: August 3, 2020

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Details for New Drug Application (NDA): 207418

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NDA 207418 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Eywa, Hi Tech, Hikma, Pharm Assoc, Rhodes Pharms, Specgx Llc, Vistapharm, Wockhardt Bio Ag, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Sun Pharm Inds Inc, Vintage Pharms, Barr Labs Inc, and Watson Labs, and is included in fifty NDAs. It is available from thirty-seven suppliers. Additional details are available on the OXYCODONE HYDROCHLORIDE profile page.

The generic ingredient in OXYCODONE HYDROCHLORIDE is ibuprofen; oxycodone hydrochloride. There are sixty-four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibuprofen; oxycodone hydrochloride profile page.
Summary for 207418
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Ascent Pharms Inc
Ingredient:oxycodone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207418
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 207418
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 207418 ANDA Camber Pharmaceuticals Inc 31722-917 31722-917-01 100 TABLET in 1 BOTTLE (31722-917-01)
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 207418 ANDA Camber Pharmaceuticals Inc 31722-917 31722-917-05 500 TABLET in 1 BOTTLE (31722-917-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Aug 7, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Aug 7, 2017TE:ABRLD:No

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