FDA.reportPublic FDA data

Application 207884

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL5MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL10MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
40032-573Methylphenidate HydrochlorideMethylphenidate HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-574Methylphenidate HydrochlorideMethylphenidate HydrochlorideNovel Laboratories, Inc.ANDACurrent
40032-575Methylphenidate HydrochlorideMethylphenidate HydrochlorideNovel Laboratories, Inc.ANDACurrent
43386-573Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-573Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-573Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-574Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-574Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-574Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-575Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-575Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-575Methylphenidate HydrochlorideMethylphenidate HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10623ORIG2015-11-18