FDA.reportPublic FDA data

Application 207551

Type
ANDA
Sponsor
AMNEAL PHARMS CO

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1388Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1388Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1389Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
70121-1389Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent