FDA.reportPublic FDA data

Application 209470

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLCHICINECOLCHICINETABLET;ORAL0.6MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1086ColchicineColchicineMylan Pharmaceuticals Inc.ANDACurrent
0378-1086ColchicineColchicineMylan Pharmaceuticals Inc.ANDACurrent
0378-1086ColchicineColchicineMylan Pharmaceuticals Inc.ANDACurrent
0378-1086ColchicineColchicineMylan Pharmaceuticals Inc.ANDACurrent
42292-054ColchicineColchicineMylan Institutional Inc.ANDACurrent
42292-054ColchicineColchicineMylan Institutional Inc.ANDACurrent
42292-054ColchicineColchicineMylan Institutional Inc.ANDACurrent
42292-054ColchicineColchicineMylan Institutional Inc.ANDACurrent