HIKMA FDA Approval ANDA 200183

ANDA 200183

HIKMA

FDA Drug Application

Application #200183

Application Sponsors

ANDA 200183HIKMA

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUSEQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)0SUMATRIPTAN SUCCINATESUMATRIPTAN SUCCINATE

FDA Submissions

N/A; Not ApplicableORIG1AP2013-09-16

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

HIKMA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200183
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUMATRIPTAN SUCCINATE","activeIngredients":"SUMATRIPTAN SUCCINATE","strength":"EQ 6MG BASE\/0.5ML (EQ 12MG BASE\/ML)","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/16\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-09-16
        )

)

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