ANDA 207241

FRESENIUS KABI USA

FDA Drug Application

Application #207241

Application Sponsors

ANDA 207241

FRESENIUS KABI USA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10MG BASE/ML

0

LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-03-14

STANDARD

Submissions Property Types

ORIG

1

Null

15

CDER Filings

FRESENIUS KABI USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207241
            [companyName] => FRESENIUS KABI USA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/14\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-03-14
        )

)