WOCKHARDT BIO AG FDA Approval ANDA 087881

ANDA 087881

WOCKHARDT BIO AG

FDA Drug Application

Application #087881

Application Sponsors

ANDA 087881WOCKHARDT BIO AG

Marketing Status

Discontinued001

Application Products

001SOLUTION;TOPICAL4%0LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE

FDA Submissions

ORIG1AP1982-11-18
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-05-14
LABELING; LabelingSUPPL7AP1989-09-06
LABELING; LabelingSUPPL8AP1992-05-28
LABELING; LabelingSUPPL9AP1994-02-16
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2002-04-15UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-08-13
LABELING; LabelingSUPPL12AP2015-10-19STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL11Null0
SUPPL12Null15

TE Codes

001PrescriptionAT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87881
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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