FDA.reportPublic FDA data

Application 075629

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLIN ERMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo
002METHYLIN ERMETHYLPHENIDATE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-1445Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1445Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1445Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1445Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1445Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1445Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1473Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1473Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1473Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1473Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1473Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1473Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23767ORIG2011-12-20
43011ORIG2001-12-05
8744ORIG2000-05-09