ANDA 040300

SPECGX LLC

FDA Drug Application

Application #040300

Documents

• Letter: 1998-11-27
• Label: 2004-06-09
• Review: 2003-07-31

Application Sponsors

ANDA 040300

SPECGX LLC

Marketing Status

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

Application Products

001	TABLET;ORAL	5MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE
003	TABLET;ORAL	20MG	0	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1998-11-27
LABELING; Labeling	SUPPL	6	AP	2006-03-02
LABELING; Labeling	SUPPL	7	AP	2010-12-10
LABELING; Labeling	SUPPL	11	AP	2012-12-19
LABELING; Labeling	SUPPL	13	AP	2014-01-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-03-20	STANDARD
LABELING; Labeling	SUPPL	17	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2016-10-28	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	15	Null	15
SUPPL	17	Null	15
SUPPL	18	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40300
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPHENIDATE HYDROCHLORIDE","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/27\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/40-300_Methylphenidate%20Hydrochloride_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLPHENIDATE HYDROCHLORIDE","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-11-27
        )

)