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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 089458

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NDA 089458 describes GLUTETHIMIDE, which is a drug marketed by Halsey, Lannett, Ucb Inc, Upsher Smith Labs, Vitarine, and Watson Labs, and is included in nine NDAs. Additional details are available on the GLUTETHIMIDE profile page.

The generic ingredient in GLUTETHIMIDE is glutethimide. There are four drug master file entries for this compound. Additional details are available on the glutethimide profile page.

Summary for 089458

Tradename:	GLUTETHIMIDE
Applicant:	Halsey
Ingredient:	glutethimide
Patents:	0

Medical Subject Heading (MeSH) Categories for 089458

Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Oct 10, 1986	TE:		RLD:	No

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