FDA.reportPublic FDA data

Application 077137

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDETABLET;ORALEQ 250MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43063-598Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-598Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-598Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-598Terbinafine HydrochlorideTerbinafine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
61919-451TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEDirectRXANDACurrent
61919-451TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDEDirectRXANDACurrent
63187-792Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63187-792Terbinafine HydrochlorideTerbinafine HydrochlorideProficient Rx LPANDACurrent
63629-8137Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
63629-8137Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
67405-500Terbinafine HydrochlorideTerbinafine HydrochlorideHarris Pharmaceutical, Inc.ANDACurrent
67405-500Terbinafine HydrochlorideTerbinafine HydrochlorideHarris Pharmaceutical, Inc.ANDACurrent
68071-1640Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1640Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1640Terbinafine HydrochlorideTerbinafine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2381TERBINAFINE HYDROCHLORIDETerbinafine Tablets 250 mgNuCare Pharmaceuticals,Inc.ANDACurrent
69097-731TERBINAFINE HYDROCHLORIDETerbinafine Tablets 250 mgCipla USA Inc.ANDACurrent
70518-3085TERBINAFINE HYDROCHLORIDETerbinafine Tablets 250 mgREMEDYREPACK INC.ANDACurrent
71335-0257Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0257Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0257Terbinafine HydrochlorideTerbinafine HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9008ORIG2007-07-05