ANDA 212160

WINDER LABS LLC

FDA Drug Application

Application #212160

Application Sponsors

ANDA 212160

WINDER LABS LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	TABLET;ORAL	2.5MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
002	TABLET;ORAL	5MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
003	TABLET;ORAL	7.5MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
004	TABLET;ORAL	10MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
005	TABLET;ORAL	15MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
006	TABLET;ORAL	20MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE
007	TABLET;ORAL	30MG	0	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AA
002	Prescription	AA
003	Prescription	AA
004	Prescription	AA
005	Prescription	AA
006	Prescription	AA
007	Prescription	AA

CDER Filings

WINDER LABS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212160
            [companyName] => WINDER LABS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"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":"7.5MG","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"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DEXTROAMPHETAMINE SULFATE","activeIngredients":"DEXTROAMPHETAMINE SULFATE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-07
        )

)