ANDA 210917

INGENUS PHARMS LLC

FDA Drug Application

Application #210917

Application Sponsors

ANDA 210917

INGENUS PHARMS LLC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 10MG BASE/ML

0

LEUCOVORIN CALCIUM

LEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-11-23

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210917
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEUCOVORIN CALCIUM","activeIngredients":"LEUCOVORIN CALCIUM","strength":"EQ 10MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/23\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-23
        )

)