ANDA 208317

FRESENIUS KABI USA

FDA Drug Application

Application #208317

Application Sponsors

ANDA 208317

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

0

ICATIBANT ACETATE

ICATIBANT ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-06-18

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208317
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ICATIBANT ACETATE","activeIngredients":"ICATIBANT ACETATE","strength":"EQ 30MG BASE\/3ML (EQ 10MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-18
        )

)