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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 205177


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NDA 205177 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 205177
Tradename:OXYCODONE HYDROCHLORIDE
Applicant:Ani Pharms
Ingredient:oxycodone hydrochloride
Patents:0
Pharmacology for NDA: 205177
Mechanism of ActionFull Opioid Agonists
Suppliers and Packaging for NDA: 205177
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYCODONE HYDROCHLORIDE oxycodone hydrochloride CAPSULE;ORAL 205177 ANDA ANI Pharmaceuticals, Inc. 62559-167 62559-167-01 100 CAPSULE in 1 BOTTLE (62559-167-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Mar 31, 2016TE:ABRLD:No

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