PLIVA FDA Approval ANDA 074101

ANDA 074101

PLIVA

FDA Drug Application

Application #074101

Application Sponsors

ANDA 074101PLIVA

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001TABLET;ORAL25MG0ATENOLOLATENOLOL
002TABLET;ORAL50MG0ATENOLOLATENOLOL
003TABLET;ORAL100MG0ATENOLOLATENOLOL

FDA Submissions

ORIG1AP1997-07-17
LABELING; LabelingSUPPL2AP2001-04-12

Submissions Property Types

ORIG1Null0
SUPPL2Null0

CDER Filings

PLIVA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74101
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ATENOLOL","activeIngredients":"ATENOLOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ATENOLOL","submission":"ATENOLOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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