ANDA 213543

CUSTOPHARM INC

FDA Drug Application

Application #213543

Application Sponsors

ANDA 213543

CUSTOPHARM INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/ML

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-01-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

CUSTOPHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213543
            [companyName] => CUSTOPHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/19\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-01-19
        )

)