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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 070444

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NDA 070444 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Halsey, Hikma, Hikma Intl Pharms, Novitium Pharma, Purepac Pharm, Rising, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-two 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 are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

Summary for 070444

Tradename:	FLURAZEPAM HYDROCHLORIDE
Applicant:	Novitium Pharma
Ingredient:	flurazepam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 070444

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:	Mar 20, 1986	TE:		RLD:	No

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