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Last Updated: April 21, 2025

Details for New Drug Application (NDA): 204021

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NDA 204021 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 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-three 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 204021

Tradename:	OXYCODONE HYDROCHLORIDE
Applicant:	Novel Labs Inc
Ingredient:	oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 204021

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 204021

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	204021	ANDA	Lupin Pharmaceuticals,Inc.	43386-430	43386-430-01	100 TABLET in 1 BOTTLE (43386-430-01)
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	204021	ANDA	Lupin Pharmaceuticals,Inc.	43386-431	43386-431-01	100 TABLET in 1 BOTTLE (43386-431-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 12, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 12, 2017	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 12, 2017	TE:		RLD:	No

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