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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 085383

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NDA 085383 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 085383

Tradename:	BUTABARBITAL SODIUM
Applicant:	Wockhardt
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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