Last Updated: November 13, 2026

Details for New Drug Application (NDA): 211925

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NDA 211925 describes CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, Tp Anda Holdings, and Usl Pharma, and is included in ten NDAs. It is available from one supplier. Additional details are available on the CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE is amitriptyline hydrochloride; chlordiazepoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the amitriptyline hydrochloride; chlordiazepoxide profile page.

Summary for 211925

Tradename:	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
Applicant:	Micro Labs
Ingredient:	amitriptyline hydrochloride; chlordiazepoxide
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG BASE;5MG
Approval Date:	Feb 2, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE;10MG
Approval Date:	Feb 2, 2022	TE:		RLD:	No

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