ECI PHARMS LLC FDA Approval ANDA 202047

ANDA 202047

ECI PHARMS LLC

FDA Drug Application

Application #202047

Application Sponsors

ANDA 202047ECI PHARMS LLC

Marketing Status

Prescription001
Prescription002

Application Products

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

FDA Submissions

N/A; Not ApplicableORIG1AP2012-12-31

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PHARMA LIFE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202047
            [companyName] => PHARMA LIFE
            [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":"12\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2012-12-31
        )

)

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