FDA.reportPublic FDA data

Application 211519

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001COLCHICINECOLCHICINETABLET;ORAL0.6MGNoNo
002COLCHICINECOLCHICINETABLET;ORAL0.3MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-039ColchicineColchicineNorthstar Rx LLC.ANDACurrent
16714-039ColchicineColchicineNorthstar Rx LLC.ANDACurrent
70710-1351ColchicineColchicineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1351ColchicineColchicineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1351ColchicineColchicineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1571ColchicineColchicineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1571ColchicineColchicineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1396ColchicineColchicineCadila Healthcare LimitedANDACurrent
70771-1396ColchicineColchicineZydus Lifesciences LimitedANDACurrent
70771-1396ColchicineColchicineCadila Healthcare LimitedANDACurrent
70771-1590ColchicineColchicineCadila Healthcare LimitedANDACurrent
70771-1590ColchicineColchicineZydus Lifesciences LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63029SUPPL2020-05-15