AJANTA PHARMA LTD FDA Approval ANDA 205523

ANDA 205523

AJANTA PHARMA LTD

FDA Drug Application

Application #205523

Application Sponsors

ANDA 205523AJANTA PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 6.25MG BASE0ALMOTRIPTAN MALATEALMOTRIPTAN MALATE
002TABLET;ORALEQ 12.5MG BASE0ALMOTRIPTAN MALATEALMOTRIPTAN MALATE

FDA Submissions

UNKNOWN; ORIG1AP2016-03-03STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205523
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALMOTRIPTAN MALATE","activeIngredients":"ALMOTRIPTAN MALATE","strength":"EQ 6.25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ALMOTRIPTAN MALATE","activeIngredients":"ALMOTRIPTAN MALATE","strength":"EQ 12.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/03\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-03-03
        )

)

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