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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 089533

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NDA 089533 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 089533

Tradename:	CHLORDIAZEPOXIDE HYDROCHLORIDE
Applicant:	Pioneer Pharms
Ingredient:	chlordiazepoxide hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jul 15, 1988	TE:		RLD:	No

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