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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 207595

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NDA 207595 describes NALBUPHINE HYDROCHLORIDE, which is a drug marketed by Abbvie, Abbott, Abraxis Pharm, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Somerset Theraps Llc, and is included in eighteen NDAs. It is available from six suppliers. Additional details are available on the NALBUPHINE HYDROCHLORIDE profile page.

The generic ingredient in NALBUPHINE HYDROCHLORIDE is nalbuphine hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nalbuphine hydrochloride profile page.

Summary for 207595

Tradename:	NALBUPHINE HYDROCHLORIDE
Applicant:	Rising
Ingredient:	nalbuphine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 207595

Analgesics, Opioid
Narcotic Antagonists
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	10MG/ML (10MG/ML)
Approval Date:	Jan 11, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS			Strength	20MG/ML (20MG/ML)
Approval Date:	Jan 11, 2019	TE:		RLD:	No

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