ANDA 206053

MYLAN LABS LTD

FDA Drug Application

Application #206053

Application Sponsors

ANDA 206053

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.02MG,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 0.01MG,N/A

0

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-10-02

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206053
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG,0.15MG; 0.025MG,0.15MG;0.03MG,0.15MG; 0.01MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/02\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-10-02
        )

)