You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

Details for New Drug Application (NDA): 072369

✉ Email this page to a colleague

« Back to Dashboard

NDA 072369 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 072369

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

Pharmacology for NDA: 072369

Medical Subject Heading (MeSH) Categories for 072369

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Suppliers and Packaging for NDA: 072369

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	072369	ANDA	Chartwell RX, LLC	62135-737	62135-737-30	30 CAPSULE in 1 BOTTLE (62135-737-30)
FLURAZEPAM HYDROCHLORIDE	flurazepam hydrochloride	CAPSULE;ORAL	072369	ANDA	Chartwell RX, LLC	62135-737	62135-737-90	90 CAPSULE in 1 BOTTLE (62135-737-90)

Profile for product number 001

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.