FDA.reportPublic FDA data

Application 204652

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCYTOSINEFLUCYTOSINECAPSULE;ORAL250MGNoNo
002FLUCYTOSINEFLUCYTOSINECAPSULE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6834FlucytosineFlucytosineMajor PharmaceuticalsANDACurrent
0904-6834FlucytosineFlucytosineMajor PharmaceuticalsANDACurrent
0904-6834FlucytosineFlucytosineMajor PharmaceuticalsANDACurrent
0904-6835FlucytosineFlucytosineMajor PharmaceuticalsANDACurrent
0904-6835FlucytosineFlucytosineMajor PharmaceuticalsANDACurrent
0904-6835FlucytosineFlucytosineMajor PharmaceuticalsANDACurrent
40032-770FlucytosineFlucytosineNovel Laboratories, Inc.ANDACurrent
40032-770FlucytosineFlucytosineNovel Laboratories, Inc.ANDACurrent
40032-771FlucytosineFlucytosineNovel Laboratories, Inc.ANDACurrent
40032-771FlucytosineFlucytosineNovel Laboratories, Inc.ANDACurrent
43386-770FlucytosineFlucytosineLupin Pharmaceuticals,Inc.ANDACurrent
43386-770FlucytosineFlucytosineLupin Pharmaceuticals,Inc.ANDACurrent
43386-770FlucytosineFlucytosineLupin Pharmaceuticals,Inc.ANDACurrent
43386-771FlucytosineFlucytosineLupin Pharmaceuticals,Inc.ANDACurrent
43386-771FlucytosineFlucytosineLupin Pharmaceuticals,Inc.ANDACurrent
43386-771FlucytosineFlucytosineLupin Pharmaceuticals,Inc.ANDACurrent
50268-331FlucytosineFlucytosineAvPAKANDACurrent
50268-331FlucytosineFlucytosineAvPAKANDACurrent
50268-332FlucytosineFlucytosineAvPAKANDACurrent
50268-332FlucytosineFlucytosineAvPAKANDACurrent
60687-352FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-352FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-352FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-352FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-352FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-363FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-363FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-363FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-363FlucytosineFlucytosineAmerican Health PackagingANDACurrent
60687-363FlucytosineFlucytosineAmerican Health PackagingANDACurrent