ALEMBIC PHARMS LTD FDA Approval ANDA 205074

ANDA 205074

ALEMBIC PHARMS LTD

FDA Drug Application

Application #205074

Application Sponsors

ANDA 205074ALEMBIC PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, ORALLY DISINTEGRATING;ORAL2.5MG0ZOLMITRIPTANZOLMITRIPTAN
002TABLET, ORALLY DISINTEGRATING;ORAL5MG0ZOLMITRIPTANZOLMITRIPTAN

FDA Submissions

UNKNOWN; ORIG1AP2016-12-01STANDARD
LABELING; LabelingSUPPL5AP2020-01-27STANDARD

Submissions Property Types

ORIG1Null15
SUPPL5Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALEMBIC PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205074
            [companyName] => ALEMBIC PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/01\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/27\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-27
        )

)

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