ANDA 203572

AUROLIFE PHARMA LLC

FDA Drug Application

Application #203572

Application Sponsors

ANDA 203572

AUROLIFE PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	0.5MG	0	LORAZEPAM	LORAZEPAM
002	TABLET;ORAL	1MG	0	LORAZEPAM	LORAZEPAM
003	TABLET;ORAL	2MG	0	LORAZEPAM	LORAZEPAM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-12-22

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203572
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LORAZEPAM","activeIngredients":"LORAZEPAM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-12-22
        )

)