HETERO LABS LTD V FDA Approval ANDA 202438

ANDA 202438

HETERO LABS LTD V

FDA Drug Application

Application #202438

Application Sponsors

ANDA 202438HETERO LABS LTD V

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL125MG0FAMCICLOVIRFAMCICLOVIR
002TABLET;ORAL250MG0FAMCICLOVIRFAMCICLOVIR
003TABLET;ORAL500MG0FAMCICLOVIRFAMCICLOVIR

FDA Submissions

UNKNOWN; ORIG1AP2014-09-10
LABELING; LabelingSUPPL3AP2020-09-03STANDARD

Submissions Property Types

ORIG1Null19
SUPPL3Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

HETERO LABS LTD V
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202438
            [companyName] => HETERO LABS LTD V
            [docInserts] => ["",""]
            [products] => [{"drugName":"FAMCICLOVIR","activeIngredients":"FAMCICLOVIR","strength":"125MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMCICLOVIR","activeIngredients":"FAMCICLOVIR","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FAMCICLOVIR","activeIngredients":"FAMCICLOVIR","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/10\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/03\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/03\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-03
        )

)

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