ANDA 210984

INGENUS PHARMS LLC

FDA Drug Application

Application #210984

Application Sponsors

ANDA 210984

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

50MG/VIAL

0

DECITABINE

DECITABINE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2019-09-16	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-03-17	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-03-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210984
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DECITABINE","activeIngredients":"DECITABINE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/16\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-09-16
        )

)