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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 084719

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NDA 084719 describes SARISOL NO. 2, which is a drug marketed by Halsey and is included in one NDA. Additional details are available on the SARISOL NO. 2 profile page.

The generic ingredient in SARISOL NO. 2 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 084719

Tradename:	SARISOL NO. 2
Applicant:	Halsey
Ingredient:	butabarbital sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

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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