Documents
Application Sponsors
NDA 022273 | SANOFI AVENTIS US | |
Marketing Status
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
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
)
)