FDA.reportPublic FDA data

Application 202881

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

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
67457-251DexmedetomidinedexmedetomidineMylan Institutional LLCANDACurrent
67457-251DexmedetomidinedexmedetomidineMylan Institutional LLCANDACurrent
67457-251DexmedetomidinedexmedetomidineMylan Institutional LLCANDACurrent
67457-251DexmedetomidinedexmedetomidineMylan Institutional LLCANDACurrent
67457-251Dexmedetomidine Hydrochloridedexmedetomidine hydrochlorideMylan Institutional LLCANDACurrent