POLYGEN PHARMS FDA Approval ANDA 213351

ANDA 213351

POLYGEN PHARMS

FDA Drug Application

Application #213351

Application Sponsors

ANDA 213351POLYGEN PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET;ORALEQ 75MG BASE0CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATE
002TABLET;ORALEQ 300MG BASE0CLOPIDOGREL BISULFATECLOPIDOGREL BISULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-07-17STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

POLYGEN PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213351
            [companyName] => POLYGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 75MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CLOPIDOGREL BISULFATE","activeIngredients":"CLOPIDOGREL BISULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/17\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-07-17
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.