ANDA 040436

SPECGX LLC

FDA Drug Application

Application #040436

Documents

• Review: 2021-01-07

Application Sponsors

ANDA 040436

SPECGX LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
002	TABLET;ORAL	10MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE

FDA Submissions

	ORIG	1	AP	2002-01-29
LABELING; Labeling	SUPPL	4	AP	2007-08-31
LABELING; Labeling	SUPPL	5	AP	2008-02-06
LABELING; Labeling	SUPPL	6	AP	2010-04-29
LABELING; Labeling	SUPPL	8	AP	2015-01-29	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-04-17	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	2017-01-04	STANDARD
LABELING; Labeling	SUPPL	22	AP	2022-02-25	STANDARD

Submissions Property Types

SUPPL	8	Null	15
SUPPL	10	Null	7
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	22	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

SPECGX LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40436
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DEXTROAMPHETAMINE SULFATE","submission":"DEXTROAMPHETAMINE SULFATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)