ANDA 065133

WOCKHARDT BIO AG

FDA Drug Application

Application #065133

Application Sponsors

ANDA 065133

WOCKHARDT BIO AG

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

0

CYCLOSPORINE

CYCLOSPORINE

FDA Submissions

	ORIG	1	AP	2004-09-17
LABELING; Labeling	SUPPL	2	AP	2006-10-10
LABELING; Labeling	SUPPL	4	AP	2010-06-16

TE Codes

001

Prescription

AB2

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65133
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)