NDA 021873

BAYER HLTHCARE

FDA Drug Application

Application #021873

Documents

• Letter: 2006-10-13
• Label: 2006-10-05
• Review: 2008-10-03

Application Sponsors

NDA 021873

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

2006-10-04

STANDARD

CDER Filings

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    [0] => Array
        (
            [ApplNo] => 21873
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)