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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 085432

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NDA 085432 describes SODIUM BUTABARBITAL, which is a drug marketed by Hikma, Ivax Sub Teva Pharms, Lannett, and Marshall Pharma, and is included in nine NDAs. Additional details are available on the SODIUM BUTABARBITAL profile page.

The generic ingredient in SODIUM BUTABARBITAL is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.

Summary for 085432

Tradename:	SODIUM BUTABARBITAL
Applicant:	Hikma
Ingredient:	butabarbital sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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