AJANTA PHARMA LTD FDA Approval ANDA 213621

ANDA 213621

AJANTA PHARMA LTD

FDA Drug Application

Application #213621

Application Sponsors

ANDA 213621AJANTA PHARMA LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORAL12.5MG0TETRABENAZINETETRABENAZINE
002TABLET;ORAL25MG0TETRABENAZINETETRABENAZINE

FDA Submissions

UNKNOWN; ORIG1AP2020-12-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AJANTA PHARMA LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213621
            [companyName] => AJANTA PHARMA LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"TETRABENAZINE","activeIngredients":"TETRABENAZINE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-12-04
        )

)

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