FDA.reportPublic FDA data

Application 207285

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOXIFLOXACIN HYDROCHLORIDEMOXIFLOXACIN HYDROCHLORIDETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-034Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-034Moxifloxacin HydrochlorideMoxifloxacin HydrochlorideNovel Laboratories, Inc.ANDACurrent