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Last Updated: October 11, 2024

Details for New Drug Application (NDA): 207418


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NDA 207418 describes OXYCODONE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Avanthi Inc, Dr Reddys Labs Sa, Genus Lifesciences, Lannett Co Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Chartwell Molecular, Hikma, Pharm Assoc, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm, Vistapharm Llc, Wes Pharma Inc, Xttrium Labs Inc, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma, Sun Pharm Inds Inc, Endo Operations, Barr Labs Inc, and Watson Labs, and is included in fifty-one NDAs. It is available from thirty-eight 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. 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
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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