Last Updated: September 24, 2026

Details for New Drug Application (NDA): 085380

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NDA 085380 describes BUTISOL SODIUM, which is a drug marketed by Meda Pharms and Pharmobedient and is included in two NDAs. Additional details are available on the BUTISOL SODIUM profile page.

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

Summary for 085380

Tradename:	BUTISOL SODIUM
Applicant:	Meda Pharms
Ingredient:	butabarbital sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	ELIXIR;ORAL			Strength	30MG/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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