ANDA 080951

IMPAX LABS

FDA Drug Application

Application #080951

Application Sponsors

ANDA 080951

IMPAX LABS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

50,000 IU

0

VITAMIN D

ERGOCALCIFEROL

FDA Submissions

	ORIG	1	AP	1973-07-13
LABELING; Labeling	SUPPL	7	AP	1988-11-22
LABELING; Labeling	SUPPL	8	AP	1991-11-13

CDER Filings

IMPAX LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80951
            [companyName] => IMPAX LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VITAMIN D","activeIngredients":"ERGOCALCIFEROL","strength":"50,000 IU","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VITAMIN D","submission":"ERGOCALCIFEROL","actionType":"50,000 IU","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)