Application 211013

Type
ANDA
Sponsor
INVENTIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINECAPSULE;ORAL75MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59746-762NITROFURANTOIN (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)Jubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-762NITROFURANTOIN (monohydrate/macrocrystals)Nitrofurantoin (monohydrate/macrocrystals)Jubilant Cadista Pharmaceuticals Inc.ANDACurrent