WOCKHARDT BIO AG FDA Approval ANDA 088450

ANDA 088450

WOCKHARDT BIO AG

FDA Drug Application

Application #088450

Application Sponsors

ANDA 088450WOCKHARDT BIO AG

Marketing Status

Prescription001

Application Products

001LOTION;TOPICAL0.025%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP1985-04-01
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1986-05-29
LABELING; LabelingSUPPL6AP1989-05-11
LABELING; LabelingSUPPL7AP1992-02-21
LABELING; LabelingSUPPL8AP1993-12-27
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-08-01
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1996-08-01
LABELING; LabelingSUPPL11AP1996-08-01
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2014-11-10

Submissions Property Types

SUPPL2Null0
SUPPL9Null0
SUPPL10Null0
SUPPL13Null0

TE Codes

001PrescriptionAT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88450
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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