Last Updated: September 29, 2026

Details for New Drug Application (NDA): 084292

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NDA 084292 describes BUTABARBITAL SODIUM, which is a drug marketed by Wockhardt, Sandoz, Solvay, Teva, Watson Labs, and Whiteworth Town Plsn, and is included in fifteen NDAs. Additional details are available on the BUTABARBITAL SODIUM profile page.

The generic ingredient in BUTABARBITAL 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 084292

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

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Feb 9, 1982	TE:		RLD:	No

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