ANDA 203054

INTAS PHARMS USA

FDA Drug Application

Application #203054

Application Sponsors

ANDA 203054

INTAS PHARMS USA

Marketing Status

• Prescription: 001
• Prescription: 002

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

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-31

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

INTAS PHARMS USA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203054
            [companyName] => INTAS PHARMS USA
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-31
        )

)