Orange Book product · Brand (NDA)
LAMISIL
TERBINAFINE HYDROCHLORIDE
At a glance
Dec 30, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 30, 1992
33 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBINAFINE HYDROCHLORIDE
Strength
1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 020192
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2007LAMISILBrand (NDA)
NDA 022071 · NOVARTIS
- 2000LAMISIL ATBrand (NDA)
NDA 021124 · KARO HLTHCARE
- 1999LAMISILBrand (NDA)
NDA 020980 · KARO HLTHCARE
- 1997LAMISILBrand (NDA)
NDA 020749 · KARO HLTHCARE
- 1996LAMISILBrand (NDA)
NDA 020539 · 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.
