Last Updated: May 3, 2026

Details for New Drug Application (NDA): 201187

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NDA 201187 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 201187

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

Pharmacology for NDA: 201187

Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for 201187

Adjuvants, Anesthesia
Analgesics, Opioid
Narcotics

Suppliers and Packaging for NDA: 201187

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	201187	ANDA	Epic Pharma, LLC	42806-330	42806-330-01	100 TABLET in 1 BOTTLE (42806-330-01)
OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	201187	ANDA	Epic Pharma, LLC	42806-331	42806-331-01	100 TABLET in 1 BOTTLE (42806-331-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 15, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 15, 2014	TE:	AB	RLD:	No

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