ANDA 210739

AMNEAL EU LTD

FDA Drug Application

Application #210739

Application Sponsors

ANDA 210739

AMNEAL EU LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	UNKNOWN	UNKNOWN	0	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE
002	INJECTABLE;INJECTION	2MG/ML	0	ARSENIC TRIOXIDE	ARSENIC TRIOXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-01-25

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210739
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARSENIC TRIOXIDE","activeIngredients":"ARSENIC TRIOXIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/25\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-25
        )

)