ANDA 210623

INGENUS PHARMS LLC

FDA Drug Application

Application #210623

Application Sponsors

ANDA 210623

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	SOLUTION;INTRAVENOUS	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)	0	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM
002	SOLUTION;INTRAVENOUS	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)	0	LEVOLEUCOVORIN CALCIUM	LEVOLEUCOVORIN CALCIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210623
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 175MG BASE\/17.5ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"},{"drugName":"LEVOLEUCOVORIN CALCIUM","activeIngredients":"LEVOLEUCOVORIN CALCIUM","strength":"EQ 250MG BASE\/25ML (EQ 10MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-03
        )

)