DR REDDYS LABS LTD FDA Approval ANDA 204344

ANDA 204344

DR REDDYS LABS LTD

FDA Drug Application

Application #204344

Application Sponsors

ANDA 204344DR REDDYS LABS LTD

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INTRAVENOUSEQ 4MG BASE/100ML0ZOLEDRONIC ACIDZOLEDRONIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2018-11-19

Submissions Property Types

ORIG1Null15

CDER Filings

DR REDDYS LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204344
            [companyName] => DR REDDYS LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/19\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-19
        )

)

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