FDA Orange Book · active-ingredient family
Amlexanox
Amlexanox: 2 brands, 0 generics; first approved Dec 17, 1996.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
2
Generics (ANDA)
0
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- AMLEXANOXULURUNDA 0217272004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG PATCH TOPICAL Discontinued — - ULURUNDA 0205111996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5% PASTE DENTAL Discontinued —
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
30 yr 1 mo ago
Most recent approval
22 yr 2 mo ago
Approvals span 1996–2004 across 2 FDA applications.
Brand (NDA) 2100%
Generic (ANDA) 00%
Amlexanox: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
