ANDA 205139

ACTAVIS LLC

FDA Drug Application

Application #205139

Application Sponsors

ANDA 205139

ACTAVIS LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

6MG/ML

0

BUSULFAN

BUSULFAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-12-08	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-04-04	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-04-04	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AP

CDER Filings

ACTAVIS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205139
            [companyName] => ACTAVIS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUSULFAN","activeIngredients":"BUSULFAN","strength":"6MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/04\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-04
        )

)