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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 084041


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NDA 084041 describes CHLORDIAZEPOXIDE HYDROCHLORIDE, which is a drug marketed by Ascot, Barr, Chartwell Rx, Ferrante, Halsey, Impax Labs, Ivax Sub Teva Pharms, Lederle, Mast Mm, Mylan, Parke Davis, Pioneer Pharms, Purepac Pharm, Roxane, Superpharm, Teva, Upsher Smith Labs, Usl Pharma, Vangard, Watson Labs, West Ward, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc, and is included in seventy-seven NDAs. It is available from ten suppliers. Additional details are available on the CHLORDIAZEPOXIDE HYDROCHLORIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE is chlordiazepoxide hydrochloride; clidinium bromide. There are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.
Summary for 084041
Tradename:CHLORDIAZEPOXIDE HYDROCHLORIDE
Applicant:Chartwell Rx
Ingredient:chlordiazepoxide hydrochloride
Patents:0
Pharmacology for NDA: 084041
Suppliers and Packaging for NDA: 084041
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CHLORDIAZEPOXIDE HYDROCHLORIDE chlordiazepoxide hydrochloride CAPSULE;ORAL 084041 ANDA Chartwell RX, LLC 62135-221 62135-221-60 60 CAPSULE in 1 BOTTLE (62135-221-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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