ANDA 206588

NESHER PHARMS

FDA Drug Application

Application #206588

Application Sponsors

ANDA 206588

NESHER PHARMS

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

UNKNOWN;	ORIG	1	AP	2016-03-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-02-09	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206588
            [companyName] => NESHER PHARMS
            [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":"03\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/09\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-02-09
        )

)