Orange Book product · Brand (NDA)
LAMISIL
TERBINAFINE HYDROCHLORIDE
At a glance
Sep 28, 2007
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 28, 2007
19 yr ago
Today
Pharmaceutical detail
Active ingredient
TERBINAFINE HYDROCHLORIDE
Strength
EQ 125MG BASE/PACKET
Dosage form
GRANULE
Route
ORAL
TE code
Not listed
Application
NDA 022071
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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
- 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.
