NDA 022045

BAYER HLTHCARE

FDA Drug Application

Application #022045

Documents

• Letter: 2007-02-02
• Review: 2008-02-22

Application Sponsors

NDA 022045

BAYER HLTHCARE

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

3MG; 0.02MG

0

YAZ

DROSPIRENONE; ETHINYL ESTRADIOL

FDA Submissions

TYPE 6; Type 6 - New Indication (no longer used)

ORIG

1

AP

2007-01-26

STANDARD

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 22045
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)