NDA 022080

NOVARTIS PHARMS

FDA Drug Application

Application #022080

Documents

• Letter: 2007-08-22
• Label: 2007-08-21
• Review: 2008-10-03
• Summary Review: 2008-10-03

Application Sponsors

NDA 022080

NOVARTIS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

5MG/100ML

0

RECLAST

ZOLEDRONIC ACID

FDA Submissions

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

ORIG

1

AP

2007-08-17

STANDARD

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22080
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)