NDA 022470

NOVARTIS

FDA Drug Application

Application #022470

Documents

• Letter: 2009-12-02
• Review: 2010-04-21
• Summary Review: 2010-04-21

Application Sponsors

NDA 022470

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

FILM;ORAL

12.5MG

0

NEXCEDE

KETOPROFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form

ORIG

1

AP

2009-11-25

STANDARD

Submissions Property Types

ORIG

1

Null

0

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22470
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXCEDE","activeIngredients":"KETOPROFEN","strength":"12.5MG","dosageForm":"FILM;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEXCEDE","submission":"KETOPROFEN","actionType":"12.5MG","submissionClassification":"FILM;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)