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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075342

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NDA 075342 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 075342

Tradename:	BUTORPHANOL TARTRATE
Applicant:	Hospira
Ingredient:	butorphanol tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075342

Analgesics, Opioid
Antitussive Agents
Narcotic Antagonists
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Nov 4, 1999	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	2MG/ML
Approval Date:	Nov 4, 1999	TE:		RLD:	No

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