FDA.reportPublic FDA data

Application 200300

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION1MG/10ML (0.1MG/ML)NoNo
002CLONIDINE HYDROCHLORIDECLONIDINE HYDROCHLORIDEINJECTABLE;INJECTION5MG/10ML (0.5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9723Clonidine HydrochlorideClonidine HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9723Clonidine HydrochlorideClonidine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9724Clonidine HydrochlorideClonidine HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9724Clonidine HydrochlorideClonidine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1346CLONIDINE HCICLONIDINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1346CLONIDINE HCICLONIDINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1346CLONIDINE HCICLONIDINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1346CLONIDINE HCICLONIDINE HCIHF Acquisition Co LLC, DBA HealthFirstANDACurrent