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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 200535

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NDA 200535 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 200535

Tradename:	OXYCODONE HYDROCHLORIDE
Applicant:	Genus Lifesciences
Ingredient:	oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 200535

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 200535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	200535	NDA	Genus Lifesciences Inc.	64950-354	64950-354-10	1 BOTTLE, PLASTIC in 1 CARTON (64950-354-10) / 100 mL in 1 BOTTLE, PLASTIC
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	200535	NDA	Genus Lifesciences Inc.	64950-354	64950-354-45	40 CUP, UNIT-DOSE in 1 CASE (64950-354-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-354-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	100MG/5ML
Approval Date:	Oct 20, 2010	TE:	AA	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Aug 22, 2013	TE:	AA	RLD:	Yes

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