Is there a generic for Mazindol?

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

What is the reference-listed drug for Mazindol?

SANOREX (NDA 017247, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Mazindol are approved?

Mazindol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Mazindol

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

Reference-listed drug:SANOREX · NDA 017247

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
SANOREXRLD×2	NOVARTIS	NDA 017247	—	Approved Prior to Jan 1, 1982
MAZANOR×2	WYETH AYERST	NDA 017980	—	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.

Mazindol — frequently asked questions

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

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