ANDA 203380

QILU

FDA Drug Application

Application #203380

Documents

• Letter: 2016-05-06

Application Sponsors

ANDA 203380

QILU

Marketing Status

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

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-05-03
LABELING; Labeling	SUPPL	3	AP	2020-06-03	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-06-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203380
            [companyName] => QILU
            [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":"05\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203380Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"06\/03\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-03
        )

)