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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 207108

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NDA 207108 describes HYDROMORPHONE HYDROCHLORIDE, which is a drug marketed by Barr, Hikma, Hospira, Hospira Inc, Rising, Watson Labs, Ascent Pharms Inc, Chartwell, Actavis Labs Fl Inc, Osmotica Pharm Us, Padagis Us, Aurolife Pharma Llc, Mpp Pharma, Nesher Pharms, and Specgx Llc, and is included in twenty-four NDAs. It is available from fourteen suppliers. Additional details are available on the HYDROMORPHONE HYDROCHLORIDE profile page.

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

Summary for 207108

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

Medical Subject Heading (MeSH) Categories for 207108

Analgesics, Opioid
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;ORAL			Strength	5MG/5ML
Approval Date:	Apr 22, 2020	TE:		RLD:	No

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