ANDA 209937

CUSTOPHARM INC

FDA Drug Application

Application #209937

Application Sponsors

ANDA 209937

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

60MG/2ML (30MG/ML)

0

SODIUM TETRADECYL SULFATE

SODIUM TETRADECYL SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-12-09

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209937
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM TETRADECYL SULFATE","activeIngredients":"SODIUM TETRADECYL SULFATE","strength":"60MG\/2ML (30MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-12-09
        )

)