ANDA 065025

ABBVIE

FDA Drug Application

Application #065025

Documents

• Review: 2001-06-07
• Letter: 2000-03-03

Application Sponsors

ANDA 065025

ABBVIE

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

CYCLOSPORINE

CYCLOSPORINE

FDA Submissions

	ORIG	1	AP	2000-03-03
LABELING; Labeling	SUPPL	2	AP	2000-08-09
BIOEQUIV; Bioequivalence	SUPPL	3	AP	2001-08-15
LABELING; Labeling	SUPPL	4	AP	2001-12-14
LABELING; Labeling	SUPPL	5	AP	2004-04-26
LABELING; Labeling	SUPPL	6	AP	2005-10-05
LABELING; Labeling	SUPPL	7	AP	2005-09-01
LABELING; Labeling	SUPPL	10	AP	2007-02-07
LABELING; Labeling	SUPPL	11	AP	2007-02-26
LABELING; Labeling	SUPPL	12	AP	2007-07-13
LABELING; Labeling	SUPPL	13	AP	2009-12-09
LABELING; Labeling	SUPPL	14	AP	2009-12-09
LABELING; Labeling	SUPPL	16	AP	2010-04-27
LABELING; Labeling	SUPPL	19	AP	2013-02-06	STANDARD
LABELING; Labeling	SUPPL	20	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-10-06	STANDARD
LABELING; Labeling	SUPPL	23	AP	2015-10-06	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	23	Null	7

TE Codes

001

Prescription

AB1

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65025
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYCLOSPORINE","activeIngredients":"CYCLOSPORINE","strength":"100MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CYCLOSPORINE","submission":"CYCLOSPORINE","actionType":"100MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)