GLAND PHARMA LTD FDA Approval ANDA 205749

ANDA 205749

GLAND PHARMA LTD

FDA Drug Application

Application #205749

Application Sponsors

ANDA 205749GLAND PHARMA LTD

Marketing Status

Prescription001
None (Tentative Approval)002

Application Products

001INJECTABLE;INTRAVENOUSEQ 4MG BASE/100ML0ZOLEDRONICZOLEDRONIC ACID
002INJECTABLE;IV (INFUSION)EQ 4MG BASE/100ML0ZOLEDRONIC ACIDZOLEDRONIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2018-06-29STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

GLAND PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205749
            [companyName] => GLAND PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLEDRONIC","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/100ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLEDRONIC ACID","activeIngredients":"ZOLEDRONIC ACID","strength":"EQ 4MG BASE\/100ML","dosageForm":"INJECTABLE;IV (INFUSION)","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-06-29
        )

)

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