Is there a generic for Hydroxystilbamidine isethionate?

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

What is the reference-listed drug for Hydroxystilbamidine isethionate?

HYDROXYSTILBAMIDINE ISETHIONATE (NDA 009166, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Hydroxystilbamidine isethionate are approved?

Hydroxystilbamidine isethionate is approved in the following dosage form: injectable.

FDA Orange Book · active-ingredient family

Hydroxystilbamidine isethionate

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

Reference-listed drug:HYDROXYSTILBAMIDINE ISETHIONATE · NDA 009166

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable

Product	Applicant	Application	TE	Approved
HYDROXYSTILBAMIDINE ISETHIONATE	SANOFI AVENTIS US	NDA 009166	—	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.

Hydroxystilbamidine isethionate — frequently asked questions

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

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