Is there a generic for Bepridil hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Bepridil hydrochloride. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Bepridil hydrochloride?

BEPADIN (NDA 019001, MEDPOINTE PHARM HLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Bepridil hydrochloride are approved?

Bepridil hydrochloride is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Bepridil hydrochloride

Bepridil hydrochloride is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:BEPADIN · NDA 019001

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
BEPADIN×3	MEDPOINTE PHARM HLC	NDA 019001	—	Dec 28, 1990
VASCOR×3	JOHNSON AND JOHNSON	NDA 019002	—	Dec 28, 1990

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.

Bepridil hydrochloride — frequently asked questions

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

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