ANDA 202182

HIKMA FARMACEUTICA

FDA Drug Application

Application #202182

Application Sponsors

ANDA 202182

HIKMA FARMACEUTICA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-06-03
LABELING; Labeling	SUPPL	2	AP	2020-10-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-10-20	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA FARMACEUTICA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202182
            [companyName] => HIKMA FARMACEUTICA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/5ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/19\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-11-19
        )

)