NDA 020499

BAYER

FDA Drug Application

Application #020499

Documents

• Review: 2003-08-08
• Pediatric Written Request: 1900-01-01

Application Sponsors

NDA 020499

BAYER

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

12.5MG

0

ACTRON

KETOPROFEN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-10-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-05-17	STANDARD

Submissions Property Types

SUPPL

2

Null

0

CDER Filings

BAYER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20499
            [companyName] => BAYER
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACTRON","activeIngredients":"KETOPROFEN","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ACTRON","submission":"KETOPROFEN","actionType":"12.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)