Application 211406

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIROLIMUSSIROLIMUSSOLUTION;ORAL1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6197SirolimusSIROLIMUSApotex CorpANDACurrent
60505-6197SirolimusSIROLIMUSApotex CorpANDACurrent
60505-6197SirolimusSIROLIMUSApotex CorpANDACurrent