UPSHER SMITH LABS FDA Approval ANDA 090544

ANDA 090544

UPSHER SMITH LABS

FDA Drug Application

Application #090544

Application Sponsors

ANDA 090544UPSHER SMITH LABS

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

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

FDA Submissions

ORIG1AP2010-10-06
LABELING; LabelingSUPPL4AP2012-12-17
LABELING; LabelingSUPPL6AP2015-10-14STANDARD
LABELING; LabelingSUPPL7AP2015-10-14STANDARD
LABELING; LabelingSUPPL8AP2015-10-14STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7
SUPPL6Null7
SUPPL7Null15
SUPPL8Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90544
            [companyName] => UPSHER SMITH LABS
            [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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