GLENMARK PHARMS LTD FDA Approval ANDA 201914

ANDA 201914

GLENMARK PHARMS LTD

FDA Drug Application

Application #201914

Application Sponsors

ANDA 201914GLENMARK PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, ORALLY DISINTEGRATING;ORALEQ 5MG BASE0RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATE
002TABLET, ORALLY DISINTEGRATING;ORALEQ 10MG BASE0RIZATRIPTAN BENZOATERIZATRIPTAN BENZOATE

FDA Submissions

N/A; Not ApplicableORIG1AP2013-07-01
LABELING; LabelingSUPPL4AP2020-01-29STANDARD
LABELING; LabelingSUPPL5AP2020-01-29STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null7
SUPPL5Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

GLENMARK PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201914
            [companyName] => GLENMARK PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 5MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"RIZATRIPTAN BENZOATE","activeIngredients":"RIZATRIPTAN BENZOATE","strength":"EQ 10MG BASE","dosageForm":"TABLET, ORALLY DISINTEGRATING;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/01\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"01\/29\/2020","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/29\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-01-29
        )

)

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