ANDA 209983

FRESENIUS KABI USA

FDA Drug Application

Application #209983

Documents

• Letter: 2022-09-08

Application Sponsors

ANDA 209983

FRESENIUS KABI USA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2018-08-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209983
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"POSACONAZOLE","activeIngredients":"POSACONAZOLE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-08-13
        )

)