WOCKHARDT BIO AG FDA Approval ANDA 070655

ANDA 070655

WOCKHARDT BIO AG

FDA Drug Application

Application #070655

Application Sponsors

ANDA 070655WOCKHARDT BIO AG

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL10MG/ML0FUROSEMIDEFUROSEMIDE

FDA Submissions

ORIG1AP1987-10-01
LABELING; LabelingSUPPL2AP1990-04-03
LABELING; LabelingSUPPL3AP1990-04-03
LABELING; LabelingSUPPL4AP1990-10-24
LABELING; LabelingSUPPL5AP1991-06-05
LABELING; LabelingSUPPL6AP1992-01-16
LABELING; LabelingSUPPL7AP1992-04-06
LABELING; LabelingSUPPL8AP1994-08-04
LABELING; LabelingSUPPL9AP1996-03-15
LABELING; LabelingSUPPL10AP1997-03-03
LABELING; LabelingSUPPL12AP2004-02-13
LABELING; LabelingSUPPL15AP2009-11-16
LABELING; LabelingSUPPL16AP2010-01-08

Submissions Property Types

SUPPL15Null8
SUPPL16Null7

TE Codes

001PrescriptionAA

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70655
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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