ANDA 090631

IMPAX LABS

FDA Drug Application

Application #090631

Application Sponsors

ANDA 090631

IMPAX LABS

Marketing Status

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

Application Products

001	TABLET, ORALLY DISINTEGRATING;ORAL	10MG;100MG	0	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA
002	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;100MG	0	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA
003	TABLET, ORALLY DISINTEGRATING;ORAL	25MG;250MG	0	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA

FDA Submissions

ORIG

1

AP

2010-06-08

Submissions Property Types

ORIG

1

Null

7

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90631
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"10MG;100MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;100MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CARBIDOPA AND LEVODOPA","activeIngredients":"CARBIDOPA; LEVODOPA","strength":"25MG;250MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"10MG;100MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;100MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CARBIDOPA AND LEVODOPA","submission":"CARBIDOPA; LEVODOPA","actionType":"25MG;250MG","submissionClassification":"TABLET, ORALLY DISINTEGRATING;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)