Is there a generic for Granisetron?

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

What is the reference-listed drug for Granisetron?

SUSTOL (NDA 022445, HERON THERAPS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Granisetron are approved?

Granisetron is approved in the following dosage forms: film, extended release, injectable.

FDA Orange Book · active-ingredient family

Granisetron

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

Reference-listed drug:SUSTOL · NDA 022445

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · film, extended release, injectable

Product	Applicant	Application	TE	Approved
SUSTOLRLD	HERON THERAPS INC	NDA 022445	—	Aug 09, 2016
SANCUSORLD	CUMBERLAND	NDA 022198	—	Sep 12, 2008

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.

Granisetron — frequently asked questions

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

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