YUNG SHIN PHARM FDA Approval ANDA 202648

ANDA 202648

YUNG SHIN PHARM

FDA Drug Application

Application #202648

Application Sponsors

ANDA 202648YUNG SHIN PHARM

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/ML (EQ 1MG BASE/ML)0GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 4MG BASE/4ML (EQ 1MG BASE/ML)0GRANISETRON HYDROCHLORIDEGRANISETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-06-29

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

YUNG SHIN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202648
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 1MG BASE\/ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GRANISETRON HYDROCHLORIDE","activeIngredients":"GRANISETRON HYDROCHLORIDE","strength":"EQ 4MG BASE\/4ML (EQ 1MG BASE\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-06-29
        )

)

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