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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 207595

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NDA 207595 describes NALBUPHINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abbvie, Dr Reddys, Hospira, Igi Labs Inc, Rising, and Somerset Theraps Llc, and is included in seventeen NDAs. It is available from five 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. Five 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:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jan 11, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/ML
Approval Date:	Jan 11, 2019	TE:		RLD:	No

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