Details for New Drug Application (NDA): 083858

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NDA 083858 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 083858

Tradename:	SODIUM BUTABARBITAL
Applicant:	Marshall Pharma
Ingredient:	butabarbital sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	32.4MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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