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Last Updated: December 28, 2024

Details for New Drug Application (NDA): 084705

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NDA 084705 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 eleven 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. Fifteen suppliers are listed for this compound. Additional details are available on the chlordiazepoxide hydrochloride; clidinium bromide profile page.

Summary for 084705

Tradename:	CHLORDIAZEPOXIDE HYDROCHLORIDE
Applicant:	Roxane
Ingredient:	chlordiazepoxide hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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