Last Updated: November 8, 2026

Details for New Drug Application (NDA): 088631

NDA 088631 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 088631

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	30MG
Approval Date:	May 1, 1985	TE:		RLD:	No

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