ANDA 211639

AUROLIFE PHARMA LLC

FDA Drug Application

Application #211639

Application Sponsors

ANDA 211639

AUROLIFE PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-04-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-02-25	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211639
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMPHETAMINE SULFATE","activeIngredients":"AMPHETAMINE SULFATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/17\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-17
        )

)