FDA.reportPublic FDA data

Application 203233

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL50MGNoNo
002NITROFURANTOINNITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsNovel Laboratories, Inc.ANDACurrent
40032-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsNovel Laboratories, Inc.ANDACurrent
40032-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsNovel Laboratories, Inc.ANDACurrent
40032-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsNovel Laboratories, Inc.ANDACurrent
43386-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsLupin Pharmaceuticals,Inc.ANDACurrent
43386-641Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsLupin Pharmaceuticals,Inc.ANDACurrent
43386-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsLupin Pharmaceuticals,Inc.ANDACurrent
43386-642Nitrofurantoin macrocrystalsNitrofurantoin macrocrystalsLupin Pharmaceuticals,Inc.ANDACurrent