NDA 207369

HETERO LABS LTD V

FDA Drug Application

Application #207369

Documents

• Letter: 2015-11-19

Application Sponsors

NDA 207369

HETERO LABS LTD V

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

60MG;30MG

2

ABACAVIR; LAMIVUDINE

ABACAVIR;LAMIVUDINE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

TA

2015-11-13

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207369
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR; LAMIVUDINE","activeIngredients":"ABACAVIR;LAMIVUDINE","strength":"60MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/13\/2015","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\\\/2015\\\/207369Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-13
        )

)