Is there a generic for Mesoridazine besylate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Mesoridazine besylate. It is available as 3 brand (NDA) applications.

What is the reference-listed drug for Mesoridazine besylate?

SERENTIL (NDA 016997, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mesoridazine besylate are approved?

Mesoridazine besylate is approved in the following dosage forms: concentrate, injectable, tablet.

FDA Orange Book · active-ingredient family

Mesoridazine besylate

Mesoridazine besylate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:SERENTIL · NDA 016997

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · concentrate, injectable, tablet

Product	Applicant	Application	TE	Approved
SERENTIL	NOVARTIS	NDA 016997	—	Approved Prior to Jan 1, 1982
SERENTIL	NOVARTIS	NDA 016775	—	Approved Prior to Jan 1, 1982
SERENTIL×4	NOVARTIS	NDA 016774	—	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.

Mesoridazine besylate — frequently asked questions

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

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