ANDA 202608

SPECGX LLC

FDA Drug Application

Application #202608

Documents

• Letter: 2013-01-03
• Review: 2013-01-22

Application Sponsors

ANDA 202608

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	27MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	36MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
003	TABLET, EXTENDED RELEASE;ORAL	54MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2012-12-28
LABELING; Labeling	SUPPL	4	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	7	AP	2016-10-28	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	4	Null	15
SUPPL	6	Null	7
SUPPL	7	Null	15

TE Codes

001	Prescription	BX
002	Prescription	BX
003	Prescription	BX

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202608
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"27MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"36MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"54MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/28\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202608Orig1s000ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2012\\\/202608Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/28\/2016","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/28\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/28\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-10-28
        )

)