FDA.reportPublic FDA data

Application 073671

Type
ANDA
Sponsor
IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsImpax GenericsANDACurrent
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsImpax GenericsANDACurrent
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1643Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLCANDACurrent
50268-623Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50268-623Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
50268-623Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsAvPAKANDACurrent
63629-4792Nitrofurantoin MacrocrystalsNitrofurantoin MacrocrystalsBryant Ranch PrepackANDACurrent