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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203638

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NDA 203638 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 203638

Tradename:	OXYCODONE HYDROCHLORIDE
Applicant:	Amneal Pharms
Ingredient:	oxycodone hydrochloride
Patents:	0

Pharmacology for NDA: 203638

Mechanism of Action	Full Opioid Agonists

Suppliers and Packaging for NDA: 203638

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	203638	ANDA	Major Pharmaceuticals	0904-6966	0904-6966-61	100 BLISTER PACK in 1 CARTON (0904-6966-61) / 1 TABLET in 1 BLISTER PACK
OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	203638	ANDA	Major Pharmaceuticals	0904-7180	0904-7180-61	100 BLISTER PACK in 1 CARTON (0904-7180-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jun 3, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 3, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Jun 3, 2014	TE:	AB	RLD:	No

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