FDA.reportPublic FDA data

Application 078595

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUMAZENILFLUMAZENILINJECTABLE;INJECTION0.5MG/5ML (0.1MG/ML)NoNo
002FLUMAZENILFLUMAZENILINJECTABLE;INJECTION1MG/10ML (0.1MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67457-444FlumazenilFlumazenilMylan Institutional LLCANDACurrent
67457-447FlumazenilFlumazenilMylan Institutional LLCANDACurrent
67457-447FlumazenilFlumazenilMylan Institutional LLCANDACurrent
67457-447FlumazenilFlumazenilMylan Institutional LLCANDACurrent