ANDA 209219

INGENUS PHARMS LLC

FDA Drug Application

Application #209219

Application Sponsors

ANDA 209219

INGENUS PHARMS LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	500MG/10ML (50MG/ML)	0	FLUOROURACIL	FLUOROURACIL
002	INJECTABLE;INJECTION	1GM/20ML (50MG/ML)	0	FLUOROURACIL	FLUOROURACIL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-12

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209219
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUOROURACIL","activeIngredients":"FLUOROURACIL","strength":"1GM\/20ML (50MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-12
        )

)