Application 076787

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

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
0641-6031FlumazenilFlumazenilWest-ward Pharmaceutical Corp.ANDACurrent
0641-6032FlumazenilFlumazenilWest-ward Pharmaceutical Corp.ANDACurrent