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Last Updated: March 28, 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, 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 072368
Tradename:FLURAZEPAM HYDROCHLORIDE
Applicant:Chartwell Rx
Ingredient:flurazepam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 072368
Medical Subject Heading (MeSH) Categories for 072368
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:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Mar 30, 1989TE:ABRLD:No

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