ANDA 201801

EMCURE PHARMS LTD

FDA Drug Application

Application #201801

Documents

• Review: 2013-05-02

Application Sponsors

ANDA 201801

EMCURE PHARMS LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

EQ 5MG BASE/100ML

0

ZOLEDRONIC ACID

ZOLEDRONIC ACID

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2013-03-29
LABELING; Labeling	SUPPL	2	AP	2015-09-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-07-18	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	2	Null	15
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201801
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 5MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/29\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2013\\\/201801Orig1s000Approv.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/18\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/24\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-07-18
        )

)