YUNG SHIN PHARM FDA Approval ANDA 209680

ANDA 209680

YUNG SHIN PHARM

FDA Drug Application

Application #209680

Application Sponsors

ANDA 209680YUNG SHIN PHARM

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 20MG BASE0ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDE
002TABLET;ORALEQ 40MG BASE0ELETRIPTAN HYDROBROMIDEELETRIPTAN HYDROBROMIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-13STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

YUNG SHIN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209680
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ELETRIPTAN HYDROBROMIDE","activeIngredients":"ELETRIPTAN HYDROBROMIDE","strength":"EQ 40MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-13
        )

)

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