FDA.reportPublic FDA data

Application 076955

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1579FLUMAZENILFLUMAZENILHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-424FlumazenilFLUMAZENILFresenius Kabi USA, LLCANDACurrent
63323-424FlumazenilFLUMAZENILFresenius Kabi USA, LLCANDACurrent
70518-3456FlumazenilFLUMAZENILREMEDYREPACK INC.ANDACurrent