ANDA 076620

ACTAVIS LABS FL INC

FDA Drug Application

Application #076620

Application Sponsors

ANDA 076620

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	10MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM
002	TABLET;ORAL	20MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM
003	TABLET;ORAL	40MG	0	FOSINOPRIL SODIUM	FOSINOPRIL SODIUM

FDA Submissions

ORIG

1

AP

2004-10-15

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76620
            [companyName] => ACTAVIS LABS FL INC
            [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
        )

)