ANDA 204378

AM REGENT

FDA Drug Application

Application #204378

Application Sponsors

ANDA 204378

AM REGENT

Marketing Status

• Discontinued: 001
• Discontinued: 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

2017-05-12

Submissions Property Types

ORIG

1

Null

15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204378
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"50MG\/10ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXALIPLATIN","activeIngredients":"OXALIPLATIN","strength":"100MG\/20ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-05-12
        )

)