ALKEM LABS LTD FDA Approval ANDA 203269

ANDA 203269

ALKEM LABS LTD

FDA Drug Application

Application #203269

Application Sponsors

ANDA 203269ALKEM LABS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 5MG BASE0RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATE
002TABLET;ORALEQ 10MG BASE0RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATE

FDA Submissions

UNKNOWN; ORIG1AP2016-02-18
LABELING; LabelingSUPPL3AP2020-01-22STANDARD
LABELING; LabelingSUPPL4AP2020-01-22STANDARD

Submissions Property Types

ORIG1Null17
SUPPL3Null7
SUPPL4Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ALKEM LABS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203269
            [companyName] => ALKEM LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/22\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/22\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/19\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-22
        )

)

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