ANDA 202472

ACTAVIS INC

FDA Drug Application

Application #202472

Application Sponsors

ANDA 202472

ACTAVIS INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-03-04
LABELING; Labeling	SUPPL	2	AP	2014-10-21	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-10-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-11-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-05-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-05-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	15

CDER Filings

ACTAVIS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202472
            [companyName] => ACTAVIS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/04\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/18\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/21\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/21\/2014","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-18
        )

)