NDA 021419

SPECGX LLC

FDA Drug Application

Application #021419

Documents

• Letter: 2002-12-19
• Letter: 2007-06-14
• Letter: 2006-08-14
• Letter: 2010-10-20
• Letter: 2013-06-18
• Letter: 2013-12-24
• Letter: 2015-04-20
• Label: 2007-06-12
• Label: 2010-10-18
• Label: 2013-06-18
• Label: 2013-12-17
• Other Important Information from FDA: 2011-12-20
• Label: 2006-08-11
• Label: 2015-04-21
• Review: 2004-10-26
• Label: 2017-01-06
• Medication Guide: 2017-01-13
• Letter: 2017-01-13
• Label: 2021-06-28
• Medication Guide: 2021-06-28
• Letter: 2021-06-29
• Letter: 2021-07-20
• Label: 2021-07-20
• Medication Guide: 2021-07-20

Application Sponsors

NDA 021419

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;ORAL	5MG/5ML	1	METHYLIN	METHYLPHENIDATE HYDROCHLORIDE
002	SOLUTION;ORAL	10MG/5ML	1	METHYLIN	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-12-19	STANDARD
LABELING; Labeling	SUPPL	3	AP	2006-08-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2010-10-18	UNKNOWN
LABELING; Labeling	SUPPL	6	AP	2013-06-14	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-12-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2014-09-15	STANDARD
LABELING; Labeling	SUPPL	9	AP	2015-04-17	901 REQUIRED
LABELING; Labeling	SUPPL	10	AP	2021-07-19	STANDARD
LABELING; Labeling	SUPPL	14	AP	2017-01-04	901 REQUIRED
LABELING; Labeling	SUPPL	20	AP	2021-06-25	901 REQUIRED

Submissions Property Types

ORIG	1	Null	31
SUPPL	4	Null	7
SUPPL	6	Null	7
SUPPL	7	Null	7
SUPPL	8	Null	0
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	14	Null	31
SUPPL	20	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21419
            [companyName] => SPECGX LLC
            [docInserts] => ["Medication Guide","http:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/021419s014lbl.pdf#page=12"]
            [products] => [{"drugName":"METHYLIN","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"METHYLIN","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/04\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021419s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2017","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021419s014lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2015","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021419s009,021475s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2013","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021419s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2013","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021419s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021419s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2007","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021419s001,021475s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2006","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021475s002,021419s003lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METHYLIN","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"5MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"METHYLIN","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-01-04
        )

)