ANDA 205412

HETERO LABS LTD V

FDA Drug Application

Application #205412

Documents

• Letter: 2014-09-29

Application Sponsors

ANDA 205412

HETERO LABS LTD V

Marketing Status

• None (Tentative Approval): 001

Application Products

001

TABLET;ORAL

600;300MG

0

ABACAVIR SULFATE; LAMIVUDINE

ABACAVIR SULFATE;LAMIVUDINE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2014-09-25

STANDARD

Submissions Property Types

ORIG

1

Null

1

CDER Filings

HETERO LABS LTD V

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205412
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE; LAMIVUDINE","activeIngredients":"ABACAVIR SULFATE;LAMIVUDINE","strength":"600;300MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/25\/2014","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205412Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/22\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-12-22
        )

)