NDA 204311

MYLAN LABS LTD

FDA Drug Application

Application #204311

Documents

• Letter: 2014-10-24

Application Sponsors

NDA 204311

MYLAN LABS LTD

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

60MG;30MG

0

ABACAVIR AND LAMIVUDINE

ABACAVIR;LAMIVUDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2014-10-23

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204311
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR AND LAMIVUDINE","activeIngredients":"ABACAVIR;LAMIVUDINE","strength":"60MG;30MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/23\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204311Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-10-23
        )

)