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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 078247

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NDA 078247 describes BUTORPHANOL TARTRATE, which is a drug marketed by Baxter Hlthcare Corp, Hikma, Hikma Farmaceutica, Hospira, Apotex, and Rising, and is included in fourteen NDAs. It is available from four suppliers. Additional details are available on the BUTORPHANOL TARTRATE profile page.

The generic ingredient in BUTORPHANOL TARTRATE is butorphanol tartrate. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the butorphanol tartrate profile page.

Summary for 078247

Tradename:	BUTORPHANOL TARTRATE
Applicant:	Hikma Farmaceutica
Ingredient:	butorphanol tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 078247

Analgesics, Opioid
Antitussive Agents
Narcotic Antagonists
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Apr 29, 2009	TE:		RLD:	No

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