UPSHER SMITH LABS FDA Approval ANDA 076188

ANDA 076188

UPSHER SMITH LABS

FDA Drug Application

Application #076188

Application Sponsors

ANDA 076188UPSHER SMITH LABS

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL10MG0FOSINOPRIL SODIUMFOSINOPRIL SODIUM
002TABLET;ORAL20MG0FOSINOPRIL SODIUMFOSINOPRIL SODIUM
003TABLET;ORAL40MG0FOSINOPRIL SODIUMFOSINOPRIL SODIUM

FDA Submissions

ORIG1AP2004-10-08

Submissions Property Types

SUPPL1Null7

CDER Filings

UPSHER SMITH LABS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76188
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FOSINOPRIL SODIUM","activeIngredients":"FOSINOPRIL SODIUM","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FOSINOPRIL SODIUM","submission":"FOSINOPRIL SODIUM","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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