ANDA 203869

JIANGSU HENGRUI MED

FDA Drug Application

Application #203869

Application Sponsors

ANDA 203869

JIANGSU HENGRUI MED

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

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

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-06-18
LABELING; Labeling	SUPPL	6	AP	2020-09-04	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203869
            [companyName] => JIANGSU HENGRUI MED
            [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"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/19\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-04
        )

)