FDA.reportPublic FDA data

Application 204820

Type
NDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MITIGARECOLCHICINECAPSULE;ORAL0.6MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-3018ColchicineColchicineHikma Pharmaceuticals USA Inc.NDACurrent
0143-3018ColchicineColchicineHikma Pharmaceuticals USA Inc.NDACurrent
0143-3018ColchicineColchicineWest-Ward Pharmaceuticals CorpNDACurrent
0904-6732ColchicineColchicineMajor PharmaceuticalsNDACurrent
0904-6732ColchicineColchicineMajor PharmaceuticalsNDACurrent
50090-3465ColchicineColchicineA-S Medication SolutionsNDACurrent
50090-3465ColchicineColchicineA-S Medication SolutionsNDACurrent
59467-318MITIGAREColchicineHikma Specialty USA Inc.NDACurrent
59467-318MITIGAREColchicineHikma Specialty USA Inc.NDACurrent
59467-318MITIGAREColchicineHikma Americas, Inc.NDACurrent
60687-358ColchicineColchicineAmerican Health PackagingNDACurrent
60687-358ColchicineColchicineAmerican Health PackagingNDACurrent
60687-358ColchicineColchicineAmerican Health PackagingNDACurrent
63629-7422ColchicineColchicineBryant Ranch PrepackNDACurrent
63629-7422ColchicineColchicineBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78501SUPPL 2024-05-20
78491SUPPL 2024-05-17
78490SUPPL 2024-05-17
74161SUPPL 2023-05-03
74159SUPPL 2023-05-03
24482ORIG2014-10-10
22967ORIG2014-10-10
43975ORIG2014-10-06
32596ORIG2014-09-30
19603ORIG2014-09-30