ANDA 212589

EYWA

FDA Drug Application

Application #212589

Documents

• Letter: 2021-10-08

Application Sponsors

ANDA 212589

EYWA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

324MG

0

QUINIDINE GLUCONATE

QUINIDINE GLUCONATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2023-01-27	UNKNOWN

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7

TE Codes

001

Prescription

AB

CDER Filings

EYWA

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(
    [0] => Array
        (
            [ApplNo] => 212589
            [companyName] => EYWA
            [docInserts] => ["",""]
            [products] => [{"drugName":"QUINIDINE GLUCONATE","activeIngredients":"QUINIDINE GLUCONATE","strength":"324MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-17
        )

)