HETERO LABS LTD V FDA Approval ANDA 203277

ANDA 203277

HETERO LABS LTD V

FDA Drug Application

Application #203277

Application Sponsors

ANDA 203277HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL150MG0LAMIVUDINELAMIVUDINE
002TABLET;ORAL300MG0LAMIVUDINELAMIVUDINE

FDA Submissions

UNKNOWN; ORIG1AP2014-01-06
LABELING; LabelingSUPPL2AP2019-09-26STANDARD
LABELING; LabelingSUPPL3AP2019-09-26STANDARD
LABELING; LabelingSUPPL4AP2019-09-26STANDARD
LABELING; LabelingSUPPL5AP2019-09-26STANDARD

Submissions Property Types

ORIG1Null19
SUPPL2Null7
SUPPL3Null7
SUPPL4Null15
SUPPL5Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203277
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LAMIVUDINE","activeIngredients":"LAMIVUDINE","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/06\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/26\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/26\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-09-26
        )

)

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