ANDA 215359

SANDOZ INC

FDA Drug Application

Application #215359

Application Sponsors

ANDA 215359

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

ARSENIC TRIOXIDE

ARSENIC TRIOXIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-12-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215359
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARSENIC TRIOXIDE","activeIngredients":"ARSENIC TRIOXIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-12-02
        )

)