ANDA 202930

GLAND PHARMA LTD

FDA Drug Application

Application #202930

Application Sponsors

ANDA 202930

GLAND PHARMA LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 4MG BASE/5ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-08-05
LABELING; Labeling	SUPPL	2	AP	2015-01-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-01-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-05-27	STANDARD
LABELING; Labeling	SUPPL	5	AP	2015-10-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2016-07-13	STANDARD

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AP

CDER Filings

GLAND PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202930
            [companyName] => GLAND PHARMA LTD
            [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":"08\/05\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/13\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/27\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/02\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/02\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/02\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-07-13
        )

)