WOCKHARDT BIO AG FDA Approval ANDA 075714

ANDA 075714

WOCKHARDT BIO AG

FDA Drug Application

Application #075714

Documents

Healthcare Professional Sheet2008-02-01

Application Sponsors

ANDA 075714WOCKHARDT BIO AG

Marketing Status

Prescription001

Application Products

001SUSPENSION;ORAL100MG/5ML0CARBAMAZEPINECARBAMAZEPINE

FDA Submissions

ORIG1AP2002-06-05
LABELING; LabelingSUPPL2AP2004-04-09
LABELING; LabelingSUPPL3AP2008-01-11
LABELING; LabelingSUPPL4AP2008-03-14
LABELING; LabelingSUPPL5AP2009-12-15
LABELING; LabelingSUPPL7AP2012-01-26

Submissions Property Types

SUPPL5Null7
SUPPL7Null15

TE Codes

001PrescriptionAB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75714
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.