Last Updated: May 11, 2026

Details for New Drug Application (NDA): 204603

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NDA 204603 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-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 204603

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

Pharmacology for NDA: 204603

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 204603

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	204603	ANDA	Lupin Pharmaceuticals, Inc.	43386-920	43386-920-60	1 BOTTLE in 1 CARTON (43386-920-60) / 30 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	100MG/5ML
Approval Date:	Apr 29, 2015	TE:		RLD:	No

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