Last Updated: November 8, 2026

Details for New Drug Application (NDA): 071808

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NDA 071808 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Halsey, Hikma, Novitium Pharma, Purepac Pharm, Rising, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-one NDAs. It is available from one supplier. Additional details are available on the FLURAZEPAM HYDROCHLORIDE profile page.

The generic ingredient in FLURAZEPAM HYDROCHLORIDE is flurazepam hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

Summary for 071808

Tradename:	FLURAZEPAM HYDROCHLORIDE
Applicant:	Halsey
Ingredient:	flurazepam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 071808

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Jan 7, 1988	TE:		RLD:	No

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