Orange Book product · Brand (NDA)
LAMISIL AT
TERBINAFINE HYDROCHLORIDE
At a glance
Mar 17, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2000
26 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBINAFINE HYDROCHLORIDE
Strength
1%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 021124
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.
- 2007LAMISILBrand (NDA)
NDA 022071 · NOVARTIS
- 1999LAMISILBrand (NDA)
NDA 020980 · KARO HLTHCARE
- 1997LAMISILBrand (NDA)
NDA 020749 · KARO HLTHCARE
- 1996LAMISILBrand (NDA)
NDA 020539 · NOVARTIS
- 1992LAMISILBrand (NDA)
NDA 020192 · NOVARTIS
- 2010TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077714 · BRECKENRIDGE PHARM
- 2007TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077511 · SUN PHARMA CANADA
- 2007TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078297 · AUROBINDO PHARMA
- 2007TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 078199 · CHARTWELL
- 2007TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077137 · CIPLA
- 2007TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077919 · EMED MEDCL
- 2007TERBINAFINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077065 · GEDEON RICHTER USA
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.
