ANDA 200407

MAYNE PHARMA

FDA Drug Application

Application #200407

Documents

• Letter: 2011-10-31

Application Sponsors

ANDA 200407

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.02MG,0.1MG;0.01MG,N/A

0

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

ETHINYL ESTRADIOL; LEVONORGESTREL

FDA Submissions

N/A; Not Applicable

ORIG

1

AP

2011-10-25

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200407
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL","activeIngredients":"ETHINYL ESTRADIOL; LEVONORGESTREL","strength":"0.02MG,0.1MG;0.01MG,N\/A","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/25\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/200407s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2011-10-25
        )

)