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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 200822

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NDA 200822 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 200822

Tradename:	OXYMORPHONE HYDROCHLORIDE
Applicant:	Hikma
Ingredient:	oxymorphone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 200822

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	40MG
Approval Date:	Jul 15, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	5MG
Approval Date:	Jul 15, 2013	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	7.5MG
Approval Date:	Jul 15, 2013	TE:		RLD:	No

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