Last Updated: November 13, 2026

Details for New Drug Application (NDA): 085764

NDA 085764 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 085764

Tradename:	BUTABARBITAL SODIUM
Applicant:	Watson Labs
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

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