FDA.reportPublic FDA data

Application 040300

Type
ANDA
Sponsor
SPECGX LLC

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
0406-1142Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1142Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1142Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1142Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1142Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1142Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1144Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1144Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1144Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1144Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1144Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1144Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1146Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1146Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1146Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1146Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1146Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
0406-1146Methylphenidate HydrochlorideMethylphenidate HydrochlorideSpecGx LLCANDACurrent
63629-3279METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDEbryant ranch prepackANDACurrent
68084-805Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-805Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-805Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-805Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-805Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-823Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-823Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-823Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-823Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
68084-823Methylphenidate HydrochlorideMethylphenidate HydrochlorideAmerican Health PackagingANDACurrent
71335-0892Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
71335-0892Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent
71335-0892Methylphenidate HydrochlorideMethylphenidate HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17765ORIG2004-06-09
22121ORIG2003-07-31
7613ORIG1998-11-27