Is there a generic for Acebutolol hydrochloride?

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

What is the reference-listed drug for Acebutolol hydrochloride?

SECTRAL (NDA 018917, PROMIUS PHARMA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Acebutolol hydrochloride are approved?

Acebutolol hydrochloride is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Acebutolol hydrochloride

Acebutolol hydrochloride 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:SECTRAL · NDA 018917

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
SECTRALRLD×2	PROMIUS PHARMA	NDA 018917	—	Dec 28, 1984

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
ACEBUTOLOL HYDROCHLORIDE×2	AMNEAL PHARM	ANDA 075047	AB	Dec 30, 1999
ACEBUTOLOL HYDROCHLORIDE×2	ANI PHARMS	ANDA 074007	AB	Oct 18, 1995
ACEBUTOLOL HYDROCHLORIDE×2	PHARMOBEDIENT	ANDA 074288	—	Apr 24, 1995

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.

Acebutolol hydrochloride — frequently asked questions

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

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