ANDA 075726

MALLINCKRODT

FDA Drug Application

Application #075726

Documents

• Letter: 2001-03-30

Application Sponsors

ANDA 075726

MALLINCKRODT

Marketing Status

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

Application Products

001	TABLET;ORAL	75MG	0	PEMOLINE	PEMOLINE
002	TABLET;ORAL	37.5MG	0	PEMOLINE	PEMOLINE
003	TABLET;ORAL	18.75MG	0	PEMOLINE	PEMOLINE

FDA Submissions

ORIG

1

AP

2001-03-30

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75726
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMOLINE","activeIngredients":"PEMOLINE","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PEMOLINE","activeIngredients":"PEMOLINE","strength":"37.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"PEMOLINE","activeIngredients":"PEMOLINE","strength":"18.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PEMOLINE","submission":"PEMOLINE","actionType":"75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PEMOLINE","submission":"PEMOLINE","actionType":"37.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"PEMOLINE","submission":"PEMOLINE","actionType":"18.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)