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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 072368

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NDA 072368 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Esjay Pharma, Halsey, Hikma, Hikma Intl Pharms, 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 072368

Tradename:	FLURAZEPAM HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	flurazepam hydrochloride
Patents:	0

Pharmacology for NDA: 072368

Medical Subject Heading (MeSH) Categories for 072368

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 072368

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	072368	ANDA	Chartwell RX, LLC	62135-736	62135-736-30	30 CAPSULE in 1 BOTTLE (62135-736-30)
FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	072368	ANDA	Chartwell RX, LLC	62135-736	62135-736-90	90 CAPSULE in 1 BOTTLE (62135-736-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Mar 30, 1989	TE:	AB	RLD:	No

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