NDA 021677

LILLY

FDA Drug Application

Application #021677

Documents

• Other Important Information from FDA: 2005-04-15
• Letter: 2004-08-25
• Label: 2004-08-19
• Review: 2006-06-08

Application Sponsors

NDA 021677

LILLY

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

500MG

0

ALIMTA

PEMETREXED

FDA Submissions

TYPE 9; Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval

ORIG

1

AP

2004-08-19

STANDARD

Submissions Property Types

ORIG

1

Null

41

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21677
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)