FDA.reportPublic FDA data

Application 061454

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMCAPSULE;ORALEQ 250MG BASENoNo
002DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMCAPSULE;ORALEQ 125MG BASENoNo
003DICLOXACILLIN SODIUMDICLOXACILLIN SODIUMCAPSULE;ORALEQ 500MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-1380Dicloxacillin SodiumDicloxacillin SodiumLiberty Pharmaceuticals, Inc.ANDACurrent
0781-2248Dicloxacillin SodiumDicloxacillin SodiumSandoz IncANDACurrent
0781-2248Dicloxacillin SodiumDicloxacillin SodiumSandoz IncANDACurrent
0781-2258Dicloxacillin SodiumDicloxacillin SodiumSandoz IncANDACurrent
0781-2258Dicloxacillin SodiumDicloxacillin SodiumSandoz IncANDACurrent
21695-124Dicloxacillin SodiumDicloxacillin SodiumRebel Distributors CorpANDACurrent
50090-1702Dicloxacillin SodiumDicloxacillin SodiumA-S Medication SolutionsANDACurrent
55289-094Dicloxacillin SodiumDicloxacillin SodiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-1350Dicloxacillin SodiumDicloxacillin SodiumBryant Ranch PrepackANDACurrent
67296-1205Dicloxacillin SodiumDicloxacillin SodiumRedPharm Drug, Inc.ANDACurrent
67296-1205Dicloxacillin SodiumDicloxacillin SodiumRedPharm Drug, Inc.ANDACurrent
67296-1205Dicloxacillin SodiumDicloxacillin SodiumRedPharm Drug, Inc.ANDACurrent