Is there a generic for Dolasetron mesylate?

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

What is the reference-listed drug for Dolasetron mesylate?

ANZEMET (NDA 020624, VALIDUS PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Dolasetron mesylate are approved?

Dolasetron mesylate is approved in the following dosage forms: injectable, tablet.

FDA Orange Book · active-ingredient family

Dolasetron mesylate

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

Reference-listed drug:ANZEMET · NDA 020624

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, tablet

Product	Applicant	Application	TE	Approved
ANZEMETRLD×3	VALIDUS PHARMS	NDA 020624	—	Sep 11, 1997
ANZEMETRLD×2	VALIDUS PHARMS	NDA 020623	—	Sep 11, 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.

Dolasetron mesylate — frequently asked questions

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

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