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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 200534

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NDA 200534 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 200534

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

Pharmacology for NDA: 200534

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 200534

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	CAPSULE;ORAL	200534	NDA	Genus Lifesciences Inc.	64950-901	64950-901-10	100 CAPSULE in 1 BOTTLE, PLASTIC (64950-901-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Oct 20, 2010	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 21, 2024
Regulatory Exclusivity Use:	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

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