ANDA 065151

AM REGENT

FDA Drug Application

Application #065151

Application Sponsors

ANDA 065151

AM REGENT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

0

CYCLOSPORINE

CYCLOSPORINE

FDA Submissions

	ORIG	1	AP	2003-10-07
LABELING; Labeling	SUPPL	3	AP	2005-06-24
LABELING; Labeling	SUPPL	4	AP	2006-10-10
LABELING; Labeling	SUPPL	9	AP	2012-01-31
LABELING; Labeling	SUPPL	10	AP	2015-06-30
LABELING; Labeling	SUPPL	13	AP	2015-06-30	STANDARD

Submissions Property Types

SUPPL	9	Null	15
SUPPL	10	Null	15
SUPPL	13	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PADAGIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65151
            [companyName] => PADAGIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"50MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"50MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)