ANDA 204368

QILU

FDA Drug Application

Application #204368

Application Sponsors

ANDA 204368

QILU

Marketing Status

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

Application Products

001	INJECTABLE;INTRAVENOUS	50MG/10ML (5MG/ML)	0	OXALIPLATIN	OXALIPLATIN
002	INJECTABLE;INTRAVENOUS	100MG/20ML (5MG/ML)	0	OXALIPLATIN	OXALIPLATIN
003	INJECTABLE;INTRAVENOUS	200MG/40ML (5MG/ML)	0	OXALIPLATIN	OXALIPLATIN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-07
LABELING; Labeling	SUPPL	3	AP	2021-11-17	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-11-17	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	5	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

QILU

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204368
            [companyName] => QILU
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/10ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/20ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"200MG\/40ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-07
        )

)