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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 091443

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NDA 091443 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 091443

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

Medical Subject Heading (MeSH) Categories for 091443

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 15, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 15, 2011	TE:	AB	RLD:	No

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