INVATECH FDA Approval ANDA 075999

ANDA 075999

INVATECH

FDA Drug Application

Application #075999

Documents

Letter2003-04-16

Application Sponsors

ANDA 075999INVATECH

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006

Application Products

001TABLET;ORAL2.5MG0LISINOPRILLISINOPRIL
002TABLET;ORAL5MG0LISINOPRILLISINOPRIL
003TABLET;ORAL10MG0LISINOPRILLISINOPRIL
004TABLET;ORAL20MG0LISINOPRILLISINOPRIL
005TABLET;ORAL30MG0LISINOPRILLISINOPRIL
006TABLET;ORAL40MG0LISINOPRILLISINOPRIL

FDA Submissions

ORIG1AP2002-07-01
LABELING; LabelingSUPPL4AP2003-03-25
LABELING; LabelingSUPPL9AP2013-02-20STANDARD
LABELING; LabelingSUPPL10AP2015-04-13STANDARD
LABELING; LabelingSUPPL11AP2015-04-13STANDARD
LABELING; LabelingSUPPL12AP2016-09-08STANDARD
LABELING; LabelingSUPPL13AP2016-09-08STANDARD

Submissions Property Types

SUPPL9Null15
SUPPL10Null15
SUPPL11Null15
SUPPL12Null7
SUPPL13Null7

CDER Filings

PHARMGEN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75999
            [companyName] => PHARMGEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LISINOPRIL","activeIngredients":"LISINOPRIL","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"LISINOPRIL","submission":"LISINOPRIL","actionType":"40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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