ANDA 202675

AUROLIFE PHARMA LLC

FDA Drug Application

Application #202675

Application Sponsors

ANDA 202675

AUROLIFE PHARMA LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	1MG	0	GLYCOPYRROLATE	GLYCOPYRROLATE
002	TABLET;ORAL	2MG	0	GLYCOPYRROLATE	GLYCOPYRROLATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-04-15
UNKNOWN;	ORIG	2	AP	2018-10-30

Submissions Property Types

ORIG	1	Null	19
ORIG	2	Null	7

TE Codes

001	Prescription	AA
002	Prescription	AA

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202675
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2018","submission":"ORIG-2","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/15\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-10-30
        )

)