ANDA 202828

INFORLIFE

FDA Drug Application

Application #202828

Application Sponsors

ANDA 202828

INFORLIFE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 5MG BASE/100ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-09-23
LABELING; Labeling	SUPPL	3	AP	2015-04-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-04-26	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-08-21	STANDARD
LABELING; Labeling	SUPPL	9	AP	2022-11-02	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-11-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2022-11-02	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AP

CDER Filings

INFORLIFE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202828
            [companyName] => INFORLIFE
            [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":"09\/23\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/21\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-08-21
        )

)