FDA.reportPublic FDA data

Application 207416

Type
ANDA
Sponsor
ASCENT PHARMS 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
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthStar Rx LLCANDACurrent
16714-821METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-822METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthStar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthStar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
16714-823METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDENorthstar Rx LLCANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-173METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.ANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-174METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.ANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceuticals Inc.ANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
31722-175METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECamber Pharmaceutical IncANDACurrent
50268-528METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-528METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-529METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-529METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
50268-529METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEAvPAKANDACurrent
63629-1920METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1920METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1920METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1922METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1922METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1922METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1924METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1924METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
63629-1924METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1219METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
71335-1219METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEBryant Ranch PrepackANDACurrent
72865-122METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-122METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-123METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-123METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-124METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent
72865-124METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEXLCare Pharmaceuticals IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10616ORIG2015-09-24