FDA.reportPublic FDA data

Application 201693

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NITROFURANTOINNITROFURANTOINSUSPENSION;ORAL25MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-450NitrofurantoinNitrofurantoinNovel Laboratories, Inc.ANDACurrent
43386-450NitrofurantoinNitrofurantoinLupin Pharmaceuticals,Inc.ANDACurrent