AJANTA PHARMA LTD FDA Approval ANDA 206714

ANDA 206714

AJANTA PHARMA LTD

FDA Drug Application

Application #206714

Application Sponsors

ANDA 206714AJANTA PHARMA LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORAL250MG0CLARITHROMYCINCLARITHROMYCIN
002TABLET;ORAL500MG0CLARITHROMYCINCLARITHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2019-04-25STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206714
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CLARITHROMYCIN","activeIngredients":"CLARITHROMYCIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-25
        )

)

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