Is there a generic for Terbinafine?

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

What is the reference-listed drug for Terbinafine?

LAMISIL AT (NDA 021958, KARO HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Terbinafine are approved?

Terbinafine is approved in the following dosage form: gel.

FDA Orange Book · active-ingredient family

Terbinafine

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

Reference-listed drug:LAMISIL AT · NDA 021958

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · gel

Product	Applicant	Application	TE	Approved
LAMISIL ATRLD	KARO HLTHCARE	NDA 021958	—	Jul 24, 2006
LAMISIL	KARO HLTHCARE	NDA 020846	—	Apr 29, 1998

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.

Terbinafine — frequently asked questions

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

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