Details for New Drug Application (NDA): 083897

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NDA 083897 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 are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.

Summary for 083897

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	48.6MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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