ANDA 065003

ABBVIE

FDA Drug Application

Application #065003

Documents

• Letter: 2000-05-12
• Review: 2003-07-31

Application Sponsors

ANDA 065003

ABBVIE

Marketing Status

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

Application Products

001	CAPSULE;ORAL	25MG	0	GENGRAF	CYCLOSPORINE
002	CAPSULE;ORAL	50MG	0	GENGRAF	CYCLOSPORINE
003	CAPSULE;ORAL	100MG	0	GENGRAF	CYCLOSPORINE

FDA Submissions

	ORIG	1	AP	2000-05-12
LABELING; Labeling	SUPPL	2	AP	2004-05-14
LABELING; Labeling	SUPPL	5	AP	2005-09-01
LABELING; Labeling	SUPPL	6	AP	2005-09-01
LABELING; Labeling	SUPPL	7	AP	2007-02-07
LABELING; Labeling	SUPPL	8	AP	2007-02-26
LABELING; Labeling	SUPPL	9	AP	2007-07-13
LABELING; Labeling	SUPPL	10	AP	2015-06-30
LABELING; Labeling	SUPPL	11	AP	2009-12-09
LABELING; Labeling	SUPPL	13	AP	2010-05-05
LABELING; Labeling	SUPPL	16	AP	2013-02-06	STANDARD
LABELING; Labeling	SUPPL	17	AP	2015-06-30	STANDARD
LABELING; Labeling	SUPPL	18	AP	2015-06-30	STANDARD

Submissions Property Types

SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	16	Null	15
SUPPL	17	Null	7
SUPPL	18	Null	15

TE Codes

001	Prescription	AB1
003	Prescription	AB1

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65003
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"GENGRAF","activeIngredients":"CYCLOSPORINE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GENGRAF","activeIngredients":"CYCLOSPORINE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GENGRAF","activeIngredients":"CYCLOSPORINE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GENGRAF","submission":"CYCLOSPORINE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GENGRAF","submission":"CYCLOSPORINE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GENGRAF","submission":"CYCLOSPORINE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)