WOCKHARDT BIO AG FDA Approval ANDA 208429

ANDA 208429

WOCKHARDT BIO AG

FDA Drug Application

Application #208429

Application Sponsors

ANDA 208429WOCKHARDT BIO AG

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 100MG BASE0IMATINIB MESYLATEIMATINIB MESYLATE
002TABLET;ORALEQ 400MG BASE0IMATINIB MESYLATEIMATINIB MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2019-01-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208429
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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