WOCKHARDT BIO AG FDA Approval ANDA 062825

ANDA 062825

WOCKHARDT BIO AG

FDA Drug Application

Application #062825

Application Sponsors

ANDA 062825WOCKHARDT BIO AG

Marketing Status

Prescription001

Application Products

001SOLUTION;TOPICAL2%0ERYTHROMYCINERYTHROMYCIN

FDA Submissions

ORIG1AP1987-10-23
LABELING; LabelingSUPPL2AP1992-02-14
LABELING; LabelingSUPPL3AP1992-03-16
LABELING; LabelingSUPPL4AP1994-08-17
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1994-06-28
LABELING; LabelingSUPPL6AP1997-07-22

Submissions Property Types

SUPPL5Null0

TE Codes

001PrescriptionAT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62825
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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