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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 204459

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NDA 204459 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in thirteen NDAs. It is available from nine suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.

Summary for 204459

Tradename:	OXYMORPHONE HYDROCHLORIDE
Applicant:	Aurolife Pharma Llc
Ingredient:	oxymorphone hydrochloride
Patents:	0

Pharmacology for NDA: 204459

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 204459

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 204459

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	204459	ANDA	Aurolife Pharma, LLC	13107-103	13107-103-01	100 TABLET in 1 BOTTLE (13107-103-01)
OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	204459	ANDA	Aurolife Pharma, LLC	13107-103	13107-103-30	30 TABLET in 1 BOTTLE (13107-103-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Apr 26, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 26, 2016	TE:	AB	RLD:	No

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