Last Updated: November 10, 2026

Details for New Drug Application (NDA): 078261

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NDA 078261 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Pai Holdings, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Genus, Mpp Pharma, Nesher Pharms, and Specgx Llc, and is included in twenty-four NDAs. It is available from thirteen suppliers. There is one patent protecting this drug. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in HYDROMORPHONE HYDROCHLORIDE is hydromorphone hydrochloride. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the hydromorphone hydrochloride profile page.

Summary for 078261

Tradename:	HYDROMORPHONE HYDROCHLORIDE
Applicant:	Rising
Ingredient:	hydromorphone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078261

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 14, 2010	TE:	AP	RLD:	No

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