YUNG SHIN PHARM FDA Approval ANDA 211318

ANDA 211318

YUNG SHIN PHARM

FDA Drug Application

Application #211318

Application Sponsors

ANDA 211318YUNG SHIN PHARM

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 500MG BASE0AZITHROMYCINAZITHROMYCIN

FDA Submissions

UNKNOWN; ORIG1AP2021-03-17STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

YUNG SHIN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211318
            [companyName] => YUNG SHIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"AZITHROMYCIN","activeIngredients":"AZITHROMYCIN","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-17
        )

)

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