FDA.report

Application 080706

Type
ANDA
Sponsor
CROWN LABS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
006ALA-CORTHYDROCORTISONECREAM;TOPICAL1%NoNo
007ALA-CORTHYDROCORTISONECREAM;TOPICAL2.5%NoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0316-0126AlacortHydrocortisoneCrown LaboratoriesANDACurrent
0316-0126AlacortHydrocortisoneCrown LaboratoriesANDACurrent
0316-0126AlacortHydrocortisoneCrown LaboratoriesANDACurrent
0316-0128AlacortHydrocortisoneCrown LaboratoriesANDACurrent
0316-0128AlacortHydrocortisoneCrown LaboratoriesANDACurrent
0316-0128AlacortHydrocortisoneCrown LaboratoriesANDACurrent
0316-0186HydrocortisoneHydrocortisoneCrown LaboratoriesANDACurrent
0316-0186HydrocortisoneHydrocortisoneCrown LaboratoriesANDACurrent
0316-0193HydrocortisoneHydrocortisoneCrown LaboratoriesANDACurrent
0316-0193HydrocortisoneHydrocortisoneCrown LaboratoriesANDACurrent
50090-2452HydrocortisoneHydrocortisoneA-S Medication SolutionsANDACurrent
50090-2452HydrocortisoneHydrocortisoneA-S Medication SolutionsANDACurrent
50090-2452HydrocortisoneHydrocortisoneA-S Medication SolutionsANDACurrent
62559-430HydrocortisoneHydrocortisoneANI Pharmaceuticals, Inc.ANDACurrent
62559-431HydrocortisoneHydrocortisoneANI Pharmaceuticals, Inc.ANDACurrent
63629-1951HydrocortisoneHydrocortisoneBryant Ranch PrepackANDACurrent
63629-1951HydrocortisoneHydrocortisoneBryant Ranch PrepackANDACurrent
63629-1952HydrocortisoneHydrocortisoneBryant Ranch PrepackANDACurrent
63629-1952HydrocortisoneHydrocortisoneBryant Ranch PrepackANDACurrent
65649-501ProctocortHYDROCORTISONESalix Pharmaceuticals, IncANDACurrent
65649-501ProctocortHYDROCORTISONESalix Pharmaceuticals, IncANDACurrent
68071-4582HydrocortisoneHydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4582HydrocortisoneHydrocortisoneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8302HydrocortisoneHydrocortisonePreferred Pharmaceuticals, Inc.ANDACurrent