FDA.reportPublic FDA data

Application 201072

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMEDETOMIDINE HYDROCHLORIDEDEXMEDETOMIDINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-421Dexmedetomidine Hydrochloridedexmedetomidine hydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-421Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-421Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-421Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-421Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideFresenius Kabi USA, LLCANDACurrent
63323-421Dexmedetomidine HydrochlorideDexmedetomidine HydrochlorideFresenius Kabi USA, LLCANDACurrent