FDA.reportPublic FDA data

Application 077002

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIGOXINDIGOXINTABLET;ORAL0.25MGNoNo
002DIGOXINDIGOXINTABLET;ORAL0.125MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1240DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1240DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1240DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1240DigoxinDigoxinWest-Ward Pharmaceuticals CorpANDACurrent
0143-1241DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1241DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1241DigoxinDigoxinWest-Ward Pharmaceuticals CorpANDACurrent
0143-1241DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1241DigoxinDigoxinHikma Pharmaceuticals USA Inc.ANDACurrent
0615-0518DigoxinDigoxinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-0547DigoxinDigoxinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8202DigoxinDigoxinNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8202DigoxinDigoxinNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-5921DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5921DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5921DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5921DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5921DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5922DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5922DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5922DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5922DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-5922DigoxinDigoxinMajor PharmaceuticalsANDACurrent
0904-6886DigoxinDigoxinMajor PharmaceuticalsANDACurrent
50090-4432DigoxinDigoxinA-S Medication SolutionsANDACurrent
50090-4449DigoxinDigoxinA-S Medication SolutionsANDACurrent
53808-0165DIGOXINDIGOXINDEPT HEALTH CENTRAL PHARMACYANDACurrent
53808-0237DigoxinDIGOXINState of Florida DOH Central PharmacyANDACurrent
53808-0355DigoxinDIGOXINState of Florida DOH Central PharmacyANDACurrent
55154-3375DigoxinDigoxinCardinal HealthANDACurrent
55154-5882DigoxinDigoxinCardinal HealthANDACurrent
55154-5882DigoxinDigoxinCardinal HealthANDACurrent
55154-5882DigoxinDigoxinCardinal Health 107, LLCANDACurrent
55154-5882DigoxinDigoxinCardinal HealthANDACurrent
58118-1240DigoxinDigoxinClinical Solutions Wholesale, LLCANDACurrent
58118-1240DigoxinDigoxinClinical Solutions Wholesale, LLCANDACurrent
60429-099DigoxinDigoxinGolden State Medical Supply Inc.ANDACurrent
60429-099DigoxinDigoxinGolden State Medical SupplyANDACurrent
60429-099DigoxinDigoxinGolden State Medical Supply IncANDACurrent
60429-100DigoxinDigoxinGolden State Medical Supply Inc.ANDACurrent
60429-100DigoxinDigoxinGolden State Medical SupplyANDACurrent
60429-100DigoxinDigoxinGolden State Medical Supply IncANDACurrent
63629-2579DigoxinDigoxinBryant Ranch PrepackANDACurrent
63629-2579DigoxinDigoxinBryant Ranch PrepackANDACurrent
63629-3870DigoxinDigoxinBryant Ranch PrepackANDACurrent
63629-3870DigoxinDigoxinBryant Ranch PrepackANDACurrent
68071-4188DigoxinDigoxinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4398DigoxinDigoxinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4469DigoxinDigoxinNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1036DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1036DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1036DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1036DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1036DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1036DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1250DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-1250DigoxinDigoxinREMEDYREPACK INC.ANDACurrent
70518-3124DigoxinDigoxinREMEDYREPACK INC.ANDACurrent