ANDA 213278

EUGIA PHARMA

FDA Drug Application

Application #213278

Application Sponsors

ANDA 213278

EUGIA PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	INJECTABLE;INJECTION	40MG/2ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE
002	INJECTABLE;INJECTION	100MG/5ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE
003	INJECTABLE;INJECTION	300MG/15ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE
004	INJECTABLE;INJECTION	500MG/25ML (20MG/ML)	0	IRINOTECAN HYDROCHLORIDE	IRINOTECAN HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-11-03

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP
004	Prescription	AP

CDER Filings

EUGIA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213278
            [companyName] => EUGIA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"300MG\/15ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-11-02
        )

)