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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 071108

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NDA 071108 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Halsey, Hikma, Hikma Intl Pharms, Purepac Pharm, Rising, Strides Pharma, 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 071108

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

Medical Subject Heading (MeSH) Categories for 071108

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Dec 8, 1986	TE:		RLD:	No

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