ANDA 212567

MYLAN LABS LTD

FDA Drug Application

Application #212567

Application Sponsors

ANDA 212567

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

40MG/ML

0

TRIAMCINOLONE ACETONIDE

TRIAMCINOLONE ACETONIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-11-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212567
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"40MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-02
        )

)