FDA.reportPublic FDA data

Application 202608

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL27MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL36MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL54MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-0127Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0127Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0127Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0127Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0127Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0136Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0136Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0136Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0136Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0136Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0154Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0154Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0154Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0154Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-0154Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43408ORIG2013-01-22
10085ORIG2013-01-03