ANDA 208789

INGENUS PHARMS LLC

FDA Drug Application

Application #208789

Application Sponsors

ANDA 208789

INGENUS PHARMS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

0

PALONOSETRON HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-05-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

INGENUS PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208789
            [companyName] => INGENUS PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.25MG BASE\/5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-05-22
        )

)