Is there a generic for Betazole hydrochloride?

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

What is the reference-listed drug for Betazole hydrochloride?

HISTALOG (NDA 009344, LILLY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Betazole hydrochloride are approved?

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

FDA Orange Book · active-ingredient family

Betazole hydrochloride

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

Reference-listed drug:HISTALOG · NDA 009344

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HISTALOG	LILLY	NDA 009344	—	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.

Betazole hydrochloride — frequently asked questions

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

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