FDA.reportPublic FDA data

Application 210425

Type
ANDA
Sponsor
GRANULES PHARMS

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
0904-7120ColchicineColchicineMajor PharmaceuticalsANDACurrent
0904-7120ColchicineColchicineMajor PharmaceuticalsANDACurrent
51407-082ColchicineColchicineGolden State Medical SupplyANDACurrent
51407-082ColchicineColchicineGolden State Medical SupplyANDACurrent
51407-082ColchicineColchicineGolden State Medical SupplyANDACurrent
70010-002ColchicineColchicineGranules Pharmaceuticals Inc.ANDACurrent
70010-002ColchicineColchicineGranules Pharmaceuticals Inc.ANDACurrent
70010-002ColchicineColchicineGranules Pharmaceuticals Inc.ANDACurrent
70010-002ColchicineColchicineGranules Pharmaceuticals Inc.ANDACurrent
70010-002ColchicineColchicineGranules Pharmaceuticals Inc.ANDACurrent
71610-494ColchicineColchicineAphena Pharma Solutions - Tennessee, LLCANDACurrent