FDA.reportPublic FDA data

Application 201676

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SIROLIMUSSIROLIMUSTABLET; ORAL0.5MGNoNo
002SIROLIMUSSIROLIMUSTABLET; ORAL1MGNoNo
003SIROLIMUSSIROLIMUSTABLET;ORAL0.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65841-771sirolimussirolimusZydus Lifesciences LimitedANDACurrent
65841-771sirolimussirolimusCadila Healthcare LimitedANDACurrent
65841-771sirolimussirolimusCadila Healthcare LimitedANDACurrent
65841-771sirolimussirolimusCadila Healthcare LimitedANDACurrent
68084-956SirolimusSirolimusAmerican Health PackagingANDACurrent
68084-956SirolimusSirolimusAmerican Health PackagingANDACurrent
68382-520sirolimussirolimusZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-520sirolimussirolimusZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-520sirolimussirolimusZydus Pharmaceuticals USA Inc.ANDACurrent
68382-520sirolimussirolimusZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-520sirolimussirolimusZydus Pharmaceuticals (USA) Inc.ANDACurrent