HETERO LABS LTD V FDA Approval ANDA 202801

ANDA 202801

HETERO LABS LTD V

FDA Drug Application

Application #202801

Documents

Letter2015-01-12

Application Sponsors

ANDA 202801HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL250MG0LEVOFLOXACINLEVOFLOXACIN
002TABLET;ORAL500MG0LEVOFLOXACINLEVOFLOXACIN
003TABLET;ORAL750MG0LEVOFLOXACINLEVOFLOXACIN

FDA Submissions

UNKNOWN; ORIG1AP2015-01-08
LABELING; LabelingSUPPL3AP2019-04-24STANDARD
LABELING; LabelingSUPPL4AP2019-04-24STANDARD
LABELING; LabelingSUPPL5AP2019-05-03STANDARD
LABELING; LabelingSUPPL13AP2022-09-27STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null15
SUPPL4Null7
SUPPL5Null7
SUPPL13Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202801
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/08\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202801Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-05-03
        )

)

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