ANDA 075629

SPECGX LLC

FDA Drug Application

Application #075629

Documents

• Letter: 2000-05-09
• Other Important Information from FDA: 2011-12-20
• Review: 2001-12-05

Application Sponsors

ANDA 075629

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	10MG	0	METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE
002	TABLET, EXTENDED RELEASE;ORAL	20MG	0	METHYLIN ER	METHYLPHENIDATE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2000-05-09
LABELING; Labeling	SUPPL	7	AP	2010-12-10
LABELING; Labeling	SUPPL	8	AP	2012-12-19
LABELING; Labeling	SUPPL	10	AP	2014-01-21	STANDARD
LABELING; Labeling	SUPPL	12	AP	2015-03-20	STANDARD
LABELING; Labeling	SUPPL	13	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-06-14	STANDARD
LABELING; Labeling	SUPPL	20	AP	2021-06-14	STANDARD
LABELING; Labeling	SUPPL	23	AP	2021-06-25	STANDARD

Submissions Property Types

SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	18	Null	15
SUPPL	20	Null	15
SUPPL	23	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75629
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLIN ER","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLIN ER","activeIngredients":"METHYLPHENIDATE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHYLIN ER","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METHYLIN ER","submission":"METHYLPHENIDATE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)