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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 201194

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NDA 201194 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, Hibrow Hlthcare, Hikma, Pharm Assoc, Pharmobedient, Quagen, Rhodes Pharms, Specgx Llc, Vistapharm Llc, Actavis Elizabeth, Alvogen, Amneal Pharms, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Strides Pharma Intl, Sun Pharm Inds Inc, Ph Health, Barr Labs Inc, and Watson Labs, and is included in fifty-one NDAs. It is available from thirty-five 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 201194

Tradename:	OXYCODONE HYDROCHLORIDE
Applicant:	Vistapharm Llc
Ingredient:	oxycodone hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 12, 2012	TE:		RLD:	Yes

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