Orange Book product · Brand (NDA)
LAMISIL AT
TERBINAFINE
Brand (NDA)NDA 021958OTC KARO HLTHCARE
At a glance
Jul 24, 2006
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 24, 2006
20 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBINAFINE
Strength
1%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 021958
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
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.
