Application 202471

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIVALIRUDINBIVALIRUDININJECTABLE;INTRAVENOUS250MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-256BivalirudinbivalirudinMylan Institutional LLCANDACurrent
67457-256BivalirudinbivalirudinMylan Institutional LLCANDACurrent
67457-256BivalirudinbivalirudinMylan Institutional LLCANDACurrent
67457-256BivalirudinbivalirudinMylan Institutional LLCANDACurrent