Is there a generic for Chlordiazepoxide?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Chlordiazepoxide, referencing the brand LIBRELEASE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Chlordiazepoxide?

LIBRELEASE (NDA 017813, VALEANT PHARM INTL) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Chlordiazepoxide are approved?

Chlordiazepoxide is approved in the following dosage forms: capsule, extended release, tablet.

FDA Orange Book · active-ingredient family

Chlordiazepoxide

Chlordiazepoxide is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LIBRELEASE · NDA 017813

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, extended release, tablet

Product	Applicant	Application	TE	Approved
LIBRELEASE	VALEANT PHARM INTL	NDA 017813	—	Sep 12, 1983

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
LIBRITABS	VALEANT PHARM INTL	ANDA 085482	—	Approved Prior to Jan 1, 1982
LIBRITABS	VALEANT PHARM INTL	ANDA 085481	—	Approved Prior to Jan 1, 1982
LIBRITABS	VALEANT PHARM INTL	ANDA 085488	—	Approved Prior to Jan 1, 1982

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 — frequently asked questions

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

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