FDA.reportPublic FDA data

Application 203583

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo
002METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGNoNo
003METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo
004METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGNoNo
005METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL50MGNoNo
006METHYLPHENIDATE HYDROCHLORIDEMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL60MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-1810Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1810Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1810Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1810Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1820Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1820Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1820Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1820Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1830Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1830Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1830Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1830Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1840Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1840Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1840Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1840Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1850Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1850Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1850Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1850Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1860Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1860Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1860Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent
0406-1860Methylphenidate Hydrochloridemethylphenidate hydrochlorideSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32446ORIG2015-10-02