ANDA 202163

BRECKENRIDGE

FDA Drug Application

Application #202163

Application Sponsors

ANDA 202163

BRECKENRIDGE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 5MG BASE/100ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-08-05
LABELING; Labeling	SUPPL	2	AP	2015-07-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-07-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2017-01-11	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AP

CDER Filings

BRECKENRIDGE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202163
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 5MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/05\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/11\/2017","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/02\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/02\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2017-01-11
        )

)