FDA Orange Book · active-ingredient family
Butenafine hydrochloride
Butenafine hydrochloride: 3 brands, 1 generic; first approved Oct 18, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
3
Generics (ANDA)
1
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- BAYER HEALTHCARE LLCNDA 0213072001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL OTC — - MENTAXRLDPHARMOBEDIENTNDA 0205241996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Discontinued — - PHARMOBEDIENTNDA 0214082002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- BUTENAFINE HYDROCHLORIDESUN PHARMA CANADAANDA 2051812017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% CREAM TOPICAL OTC —
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 3 mo ago
Most recent approval
8 yr 11 mo ago
Approvals span 1996–2017 across 4 FDA applications.
Brand (NDA) 375%
Generic (ANDA) 125%
Butenafine hydrochloride: 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.
