Orange Book product · Generic (ANDA)
TERBINAFINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE
At a glance
Jun 04, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 04, 2010
16 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TERBINAFINE HYDROCHLORIDE
Strength
EQ 250MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 077714
Product number
001
Marketing status
DISCN
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
- 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.
