FDA.reportPublic FDA data

Application 204602

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL5MG/5MLNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDESOLUTION;ORAL10MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-930Methylphenidate HydrochlorideMethylphenidate HydrochlorideNovel laboratories, Inc.ANDACurrent
40032-931Methylphenidate HydrochlorideMethylphenidate HydrochlorideNovel laboratories, Inc.ANDACurrent
43386-930Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-930Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-930Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-931Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-931Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-931Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent