FDA.reportPublic FDA data

Application 205005

Type
ANDA
Sponsor
ZYDUS PHARMS

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
0904-7025nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsANDACurrent
0904-7025nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsANDACurrent
0904-7025nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsANDACurrent
0904-7026nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsANDACurrent
0904-7026nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsANDACurrent
0904-7026nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsMajor PharmaceuticalsANDACurrent
68071-4688nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4688nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsNuCare Pharmaceuticals,Inc.ANDACurrent
68382-559nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-559nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-559nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-559nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-560nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-560nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-560nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-560nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1170nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1170nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1170nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1170nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1171nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1171nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1171nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
70771-1171nitrofurantoin macrocrystalsnitrofurantoin macrocrystalsCadila Healthcare LimitedANDACurrent
71335-1069nitrofurantoinnitrofurantoin macrocrystalsBryant Ranch PrepackANDACurrent
71335-1069nitrofurantoinnitrofurantoin macrocrystalsBryant Ranch PrepackANDACurrent