NDA 022042

LILLY

FDA Drug Application

Application #022042

Documents

• Letter: 2007-09-25
• Label: 2007-09-14
• Review: 2009-03-12
• Medication Guide: 2009-11-18

Application Sponsors

NDA 022042

LILLY

Marketing Status

• Prescription: 001

Application Products

001

TABLET; ORAL

60MG

0

EVISTA

RALOXIFENE HYDROCHLORIDE

FDA Submissions

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

ORIG

1

AP

2007-09-13

STANDARD

Submissions Property Types

ORIG

1

Orphan

5

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22042
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)