ANDA 078035

ACTAVIS LABS FL INC

FDA Drug Application

Application #078035

Documents

• Review: 2013-10-23

Application Sponsors

ANDA 078035

ACTAVIS LABS FL INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

0.5MG

0

CABERGOLINE

CABERGOLINE

FDA Submissions

	ORIG	1	AP	2008-04-21
LABELING; Labeling	SUPPL	5	AP	2013-01-31	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	2021-04-16	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	10	Null	7
SUPPL	11	Null	15

CDER Filings

ACTAVIS LABS FL INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78035
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CABERGOLINE","activeIngredients":"CABERGOLINE","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CABERGOLINE","submission":"CABERGOLINE","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)