STRIDES PHARMA FDA Approval ANDA 090382

ANDA 090382

STRIDES PHARMA

FDA Drug Application

Application #090382

Application Sponsors

ANDA 090382STRIDES PHARMA

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; LabelingSUPPL3AP2012-12-19
LABELING; LabelingSUPPL8AP2012-12-19STANDARD
LABELING; LabelingSUPPL9AP2013-05-28STANDARD
LABELING; LabelingSUPPL11AP2015-11-20STANDARD
LABELING; LabelingSUPPL12AP2016-05-10STANDARD
LABELING; LabelingSUPPL16AP2021-12-03STANDARD
LABELING; LabelingSUPPL27AP2021-12-03STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL8Null7
SUPPL9Null7
SUPPL11Null7
SUPPL12Null7
SUPPL16Null15
SUPPL27Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

STRIDES PHARMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90382
            [companyName] => STRIDES PHARMA
            [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
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.