Last Updated: November 8, 2026

Details for New Drug Application (NDA): 070345

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NDA 070345 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 070345

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

Medical Subject Heading (MeSH) Categories for 070345

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Nov 27, 1985	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Nov 27, 1985	TE:	AB	RLD:	No

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