FDA.reportPublic FDA data

Application 206407

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)NoNo
002DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)NoNo
003DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1MG BASE/250ML (EQ 4MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9525Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9526Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent