NDC 50066-080

Silka Antifungal

Terbinafine Hydrochloride

Silka Antifungal is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Genomma Lab Usa, Inc.. The primary component is Terbinafine Hydrochloride.

Product ID50066-080_643e3ebb-9ae5-4c8a-985d-94807195e055
NDC50066-080
Product TypeHuman Otc Drug
Proprietary NameSilka Antifungal
Generic NameTerbinafine Hydrochloride
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2007-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA077511
Labeler NameGenomma Lab USA, Inc.
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 50066-080-02

1 TUBE in 1 CARTON (50066-080-02) > 30 g in 1 TUBE
Marketing Start Date2007-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50066-080-05 [50066008005]

Silka Antifungal CREAM
Marketing CategoryANDA
Application NumberANDA077511
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-20

NDC 50066-080-02 [50066008002]

Silka Antifungal CREAM
Marketing CategoryANDA
Application NumberANDA077511
Product TypeHUMAN OTC DRUG
Marketing Start Date2007-07-02

NDC 50066-080-03 [50066008003]

Silka Antifungal CREAM
Marketing CategoryANDA
Application NumberANDA077511
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-05-21

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE1 g/100g

OpenFDA Data

SPL SET ID:a32cf699-e63e-4bd3-a5af-9e1ba447e02e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992528
  • 1739221

    • NDC Crossover Matching brand name "Silka Antifungal" or generic name "Terbinafine Hydrochloride"

    NDCBrand NameGeneric Name
    50066-080Silka AntifungalSilka Antifungal
    41250-080AntifungalTerbinafine Hydrochloride
    41520-080Antifungal FootTerbinafine Hydrochloride
    11673-080Athletes FootTerbinafine Hydrochloride
    11822-0080Athletes FootTerbinafine Hydrochloride
    21130-080Athletes FootTerbinafine Hydrochloride
    36800-080Athletes FootTerbinafine Hydrochloride
    37808-080Athletes FootTerbinafine Hydrochloride
    41163-080athletes footTerbinafine Hydrochloride
    24385-524Good Neighbor PharmacyTerbinafine Hydrochloride
    0179-8715KAISER PERMANENTETerbinafine Hydrochloride
    30142-080KrogerTerbinafine Hydrochloride
    0067-3998LamisilTERBINAFINE HYDROCHLORIDE
    0067-3999LamisilTERBINAFINE HYDROCHLORIDE
    0067-6292LAMISILTERBINAFINE HYDROCHLORIDE
    0067-6293LAMISILTERBINAFINE HYDROCHLORIDE
    0067-6296LAMISILTERBINAFINE HYDROCHLORIDE
    0067-6297LAMISILTERBINAFINE HYDROCHLORIDE
    0078-0179Lamisilterbinafine hydrochloride
    0067-8100Lamisil ATTerbinafine Hydrochloride
    0067-8114Lamisil ATTerbinafine Hydrochloride
    37012-080ShopkoTerbinafine Hydrochloride
    41190-083ShopRiteTerbinafine Hydrochloride
    16714-795TerbinafineTerbinafine Hydrochloride
    0363-2083Terbinafine HydrochlorideTerbinafine Hydrochloride
    0536-1117Terbinafine HydrochlorideTerbinafine Hydrochloride
    16714-501terbinafine hydrochlorideterbinafine hydrochloride
    21695-630Terbinafine HydrochlorideTerbinafine Hydrochloride
    37205-941Terbinafine HydrochlorideTerbinafine Hydrochloride
    0363-2080WalgreensTerbinafine Hydrochloride

    Trademark Results [Silka]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SILKA
    SILKA
    90324381 not registered Live/Pending
    silka kirtasiye imalat san. ve tic. ltd. sti
    2020-11-17
    SILKA
    SILKA
    86579232 not registered Live/Pending
    2545-2509 QUEBEC INC.
    2015-03-27
    SILKA
    SILKA
    86012648 4545152 Live/Registered
    Genomma Lab Internacional, S.A.B. de C.V.
    2013-07-17
    SILKA
    SILKA
    79277910 not registered Live/Pending
    KARADENIZ PRES MOBILYA INSAAT VE OTOMOTIV SANAYI TICARET LIMITED SIRKETI
    2019-11-04
    SILKA
    SILKA
    75656499 not registered Dead/Abandoned
    Meredith, Spencer B.
    1999-03-09
    SILKA
    SILKA
    73518707 1358301 Dead/Cancelled
    SOCIETE DES PRODUITS NESTLE S.A.
    1985-01-23
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