ANDA 205921

MYLAN LABS LTD

FDA Drug Application

Application #205921

Documents

• Letter: 2014-08-28

Application Sponsors

ANDA 205921

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

400MG

0

NEVIRAPINE

NEVIRAPINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-08-26

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205921
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEVIRAPINE","activeIngredients":"NEVIRAPINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205921Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-08-26
        )

)