SANDOZ INC FDA Approval ANDA 090237

ANDA 090237

SANDOZ INC

FDA Drug Application

Application #090237

Application Sponsors

ANDA 090237SANDOZ INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL5MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL
002TABLET;ORAL20MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL
003TABLET;ORAL40MG0OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL

FDA Submissions

ORIG1AP2020-04-13

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90237
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"OLMESARTAN MEDOXOMIL","activeIngredients":"OLMESARTAN MEDOXOMIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OLMESARTAN MEDOXOMIL","submission":"OLMESARTAN MEDOXOMIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLMESARTAN MEDOXOMIL","submission":"OLMESARTAN MEDOXOMIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"OLMESARTAN MEDOXOMIL","submission":"OLMESARTAN MEDOXOMIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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