BAYER HLTHCARE FDA Approval NDA 021674

NDA 021674

BAYER HLTHCARE

FDA Drug Application

Application #021674

Documents

Letter2004-06-10
Label2004-06-10
Review2006-01-03
Other2015-10-06

Application Sponsors

NDA 021674BAYER HLTHCARE

Marketing Status

Prescription001

Application Products

001FILM, EXTENDED RELEASE;TRANSDERMAL0.014MG/24HR1MENOSTARESTRADIOL

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)ORIG1AP2004-06-08STANDARD

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21674
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

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