FDA.reportPublic FDA data

Application 214505

Type
ANDA
Sponsor
HONG KONG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MITOMYCINMITOMYCININJECTABLE;INJECTION5MG/VIALNoNo
002MITOMYCINMITOMYCININJECTABLE;INJECTION20MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71288-137MITOMYCINMITOMYCINMeitheal Pharmaceuticals Inc.ANDACurrent
71288-138MITOMYCINMITOMYCINMeitheal Pharmaceuticals Inc.ANDACurrent