ANDA 206201

MAYNE PHARMA INC

FDA Drug Application

Application #206201

Application Sponsors

ANDA 206201

MAYNE PHARMA INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

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

0

ETHINYL ESTRADIOL; LEVONORGESTREL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

UNKNOWN;

ORIG

1

TA

2017-04-28

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206201
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETHINYL ESTRADIOL; LEVONORGESTREL","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":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/28\/2017","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-04-28
        )

)