Orange Book product · Generic (ANDA)
TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE
At a glance
Jul 02, 2007
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 02, 2007
19 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBINAFINE HYDROCHLORIDE
Strength
EQ 250MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 078157
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TERBINAFINE HYDROCHLORIDE
- 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
- 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
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.
