NDA 022273

SANOFI AVENTIS US

FDA Drug Application

Application #022273

Documents

• Label: 2009-07-23
• Review: 2009-05-28
• Summary Review: 2009-05-28
• Letter: 2008-12-29
• Letter: 2009-11-24
• Label: 2009-01-02

Application Sponsors

NDA 022273

SANOFI AVENTIS US

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

10MG

0

OFORTA

FLUDARABINE PHOSPHATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2008-12-18

STANDARD

Submissions Property Types

ORIG

1

Null

14

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22273
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"OFORTA","activeIngredients":"FLUDARABINE PHOSPHATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/17\/2009","submission":"SUPPL-1","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022273s001lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022273lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OFORTA","submission":"FLUDARABINE PHOSPHATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-07-17
        )

)