Is there a generic for Arbutamine hydrochloride?

The FDA Orange Book does not currently list an approved generic (ANDA) for Arbutamine hydrochloride. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Arbutamine hydrochloride?

GENESA (NDA 020420, GENSIA AUTOMEDICS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Arbutamine hydrochloride are approved?

Arbutamine hydrochloride is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Arbutamine hydrochloride

Arbutamine hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:GENESA · NDA 020420

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
GENESA	GENSIA AUTOMEDICS	NDA 020420	—	Sep 12, 1997

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.

Arbutamine hydrochloride — frequently asked questions

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

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