Is there a generic for Amlexanox?

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

What is the reference-listed drug for Amlexanox?

AMLEXANOX (NDA 021727, ULURU) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Amlexanox are approved?

Amlexanox is approved in the following dosage forms: paste, patch.

FDA Orange Book · active-ingredient family

Amlexanox

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

Reference-listed drug:AMLEXANOX · NDA 021727

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · paste, patch

Product	Applicant	Application	TE	Approved
AMLEXANOX	ULURU	NDA 021727	—	Sep 29, 2004
APHTHASOL	ULURU	NDA 020511	—	Dec 17, 1996

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.

Amlexanox — frequently asked questions

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

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