ANDA 209873

STI PHARMA LLC

FDA Drug Application

Application #209873

Application Sponsors

ANDA 209873

STI PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

ARSENIC TRIOXIDE

ARSENIC TRIOXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-05-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

STI PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209873
            [companyName] => STI PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARSENIC TRIOXIDE","activeIngredients":"ARSENIC TRIOXIDE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-05-06
        )

)