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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217385

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NDA 217385 describes CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE, which is a drug marketed by Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc, and is included in thirteen NDAs. It is available from thirteen suppliers. Additional details are available on the CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE 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 217385

Tradename:	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Applicant:	Torrent
Ingredient:	chlordiazepoxide hydrochloride; clidinium bromide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG;2.5MG
Approval Date:	Dec 14, 2023	TE:		RLD:	No

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