Is there a generic for Chlordiazepoxide hydrochloride; clidinium bromide?

Yes. The FDA Orange Book lists 13 approved generic (ANDA) applications for Chlordiazepoxide hydrochloride; clidinium bromide, referencing the brand LIBRAX. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chlordiazepoxide hydrochloride; clidinium bromide?

LIBRAX (NDA 012750, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chlordiazepoxide hydrochloride; clidinium bromide are approved?

Chlordiazepoxide hydrochloride; clidinium bromide is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Chlordiazepoxide hydrochloride; clidinium bromide

Chlordiazepoxide hydrochloride; clidinium bromide is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LIBRAX · NDA 012750

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
LIBRAXRLD	BAUSCH	NDA 012750	AB	Approved Prior to Jan 1, 1982

Generic (ANDA) products (13)

Product	Applicant	Application	TE	Approved
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	WINDER LABS LLC	ANDA 212344	AB	Jul 08, 2024
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	TORRENT	ANDA 217385	—	Dec 14, 2023
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	ALEMBIC	ANDA 216969	AB	Sep 15, 2023
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	AUROBINDO PHARMA LTD	ANDA 216419	AB	Sep 14, 2023
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	COREPHARMA	ANDA 215453	AB	Jul 29, 2022
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	MICRO LABS	ANDA 215835	AB	Jul 19, 2022
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	TEVA PHARMS USA	ANDA 211476	—	Nov 02, 2021
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	AMNEAL	ANDA 215555	AB	Oct 25, 2021
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	DR REDDYS	ANDA 214698	AB	May 10, 2021
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	ALKEM LABS LTD	ANDA 214065	AB	Apr 26, 2021
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	CHARTWELL RX	ANDA 213530	AB	Oct 20, 2020
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	MISEMER	ANDA 210579	AB	Jul 29, 2020
CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	NUVO PHARMS INC	ANDA 211421	AB	Jul 07, 2020

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Chlordiazepoxide hydrochloride; clidinium bromide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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