ZYDUS PHARMS USA INC FDA Approval ANDA 078243

ANDA 078243

ZYDUS PHARMS USA INC

FDA Drug Application

Application #078243

Application Sponsors

ANDA 078243ZYDUS PHARMS USA INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL25MG0LOSARTAN POTASSIUMLOSARTAN POTASSIUM
002TABLET;ORAL50MG0LOSARTAN POTASSIUMLOSARTAN POTASSIUM
003TABLET;ORAL100MG0LOSARTAN POTASSIUMLOSARTAN POTASSIUM

FDA Submissions

ORIG1AP2010-10-06
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2015-06-10
LABELING; LabelingSUPPL4AP2011-03-22
LABELING; LabelingSUPPL6AP2012-01-03
LABELING; LabelingSUPPL7AP2012-12-19
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2012-07-20
LABELING; LabelingSUPPL12AP2013-03-19STANDARD
LABELING; LabelingSUPPL14AP2014-09-21STANDARD
LABELING; LabelingSUPPL16AP2014-09-21STANDARD
LABELING; LabelingSUPPL19AP2015-06-10STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL6Null15
SUPPL7Null15
SUPPL9Null15
SUPPL12Null15
SUPPL14Null7
SUPPL16Null7
SUPPL19Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ZYDUS PHARMS USA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78243
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LOSARTAN POTASSIUM","activeIngredients":"LOSARTAN POTASSIUM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LOSARTAN POTASSIUM","submission":"LOSARTAN POTASSIUM","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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