ANDA 078834

MAYNE PHARMA

FDA Drug Application

Application #078834

Documents

• Letter: 2011-06-02

Application Sponsors

ANDA 078834

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

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

0

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

ORIG

1

AP

2011-05-31

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78834
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.03MG,0.01MG;0.15MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL","submission":"ETHINYL ESTRADIOL; LEVONORGESTREL","actionType":"0.03MG,0.01MG;0.15MG,N\/A","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)