FDA.reportPublic FDA data

Application 077511

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDECREAM;TOPICAL1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-8100Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0067-8100Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0067-8114Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0067-8114Lamisil ATTerbinafine HydrochlorideGlaxoSmithKline Consumer Healthcare Holdings (US) LLCANDACurrent
0179-8715KAISER PERMANENTETerbinafine HydrochlorideKaiser Foundation HospitalsANDACurrent
0363-2080WalgreensTerbinafine HydrochlorideWalgreen CompanyANDACurrent
0363-2080WalgreensTerbinafine HydrochlorideWalgreen CompanyANDACurrent
0363-2083Terbinafine HydrochlorideTerbinafine HydrochlorideWalgreen CompanyANDACurrent
0536-1117Terbinafine HydrochlorideTerbinafine HydrochlorideRugby Laboratories, Inc.ANDACurrent
0536-1117Terbinafine HydrochlorideTerbinafine HydrochlorideRugby Laboratories, Inc.ANDACurrent
11673-080Athletes FootTerbinafine HydrochlorideTarget CorporationANDACurrent
11673-080Athletes FootTerbinafine HydrochlorideTarget CorporationANDACurrent
11822-0080Athletes FootTerbinafine HydrochlorideRite Aid CorporationANDACurrent
21130-080Athletes FootTerbinafine HydrochlorideSafeway Inc.ANDACurrent
24385-524Good Neighbor PharmacyTerbinafine HydrochlorideAmerisourceBergenANDACurrent
24385-524Good Neighbor PharmacyTerbinafine HydrochlorideAmerisourceBergenANDACurrent
30142-080KrogerTerbinafine HydrochlorideKroger CompanyANDACurrent
30142-080KrogerTerbinafine HydrochlorideKroger CompanyANDACurrent
36800-080Athletes FootTerbinafine HydrochlorideTopco Associates LLCANDACurrent
37012-080ShopkoTerbinafine HydrochlorideShopko Stores Operating Co., LLCANDACurrent
37205-941Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal HealthANDACurrent
37205-941Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal HealthANDACurrent
37808-080Athletes FootTerbinafine HydrochlorideH E BANDACurrent
41163-080athletes footTerbinafine HydrochlorideSupervalu IncANDACurrent
41190-083ShopRiteTerbinafine HydrochlorideWAKEFERN FOOD CORPORATIONANDACurrent
41250-080AntifungalTerbinafine HydrochlorideMeijer Distribution IncANDACurrent
41250-080AntifungalTerbinafine HydrochlorideMeijer Distribution IncANDACurrent
41250-080AntifungalTerbinafine HydrochlorideMeijer Distribution IncANDACurrent
41520-080Antifungal FootTerbinafine HydrochlorideAmerican Sales CompanyANDACurrent
41520-080Antifungal FootTerbinafine HydrochlorideAmerican Sales CompanyANDACurrent
49035-080equateTerbinafine HydrochlorideWal-Mart Stores IncANDACurrent
49348-790Athletes FootTerbinafine HydrochlorideMcKessonANDACurrent
49348-790Athletes FootTerbinafine HydrochlorideStrategic Sourcing Services LLCANDACurrent
50066-080SilkaTerbinafine HydrochlorideGenomma Lab USA, Inc.ANDACurrent
50066-080SilkaTerbinafine HydrochlorideGenomma Lab USA, Inc.ANDACurrent
50066-208SilkaTerbinafine HydrochlorideGenomma Lab USA, Inc.ANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-1278Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5810Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5810Terbinafine HydrochlorideTerbinafine HydrochlorideA-S Medication SolutionsANDACurrent
50804-080GoodSenseTerbinafine HydrochlorideGeiss, Destin & Dunn, Inc.ANDACurrent
51143-080Live BetterTerbinafine HydrochlorideThe Great Atlantic & Pacific Tea CompanyANDACurrent
51672-2080Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2080Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2083Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2140Terbinafine HydrochlorideTerbinafine HydrochlorideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51769-121SilkaTerbinafine HydrochlorideAll Natural DynamicsANDACurrent
56062-080Athletes FootTerbinafine HydrochloridePublix Super Markets Inc.ANDACurrent
59779-080CVS PharmacyTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-080CVS PharmacyTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-080CVS PharmacyTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-523CVSTerbinafine HydrochlorideCVS PharmacyANDACurrent
59779-523CVSTerbinafine HydrochlorideCVS PharmacyANDACurrent
61715-158Preferred PlusTerbinafine HydrochloridePreferred Plus (Kinray)ANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-111Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63868-364Athletes FootTerbinafine HydrochlorideChain Drug Marketing Association, Inc.ANDACurrent
68016-080Terbinafine HydrochlorideTerbinafine HydrochloridePharmacy Value Alliance LLCANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred Pharmaceuticals, IncANDACurrent
68788-9814Terbinafine HydrochlorideTerbinafine HydrochloridePreferred PharmaceuticalsANDACurrent
70000-0338Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal Health, 110 dba LEADERANDACurrent
70000-0338Terbinafine HydrochlorideTerbinafine HydrochlorideCardinal HealthANDACurrent
70518-0553Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0553Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0553Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0670Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0670Terbinafine HydrochlorideTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1736Lamisil ATTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1736Lamisil ATTerbinafine HydrochlorideREMEDYREPACK INC.ANDACurrent
73467-121SilkaTerbinafine HydrochloridePCGI WholesaleANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43123ORIG2012-03-28