BAXTER HLTHCARE CORP FDA Approval ANDA 202747

ANDA 202747

BAXTER HLTHCARE CORP

FDA Drug Application

Application #202747

Application Sponsors

ANDA 202747BAXTER HLTHCARE CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION10MG/ML0FUROSEMIDEFUROSEMIDE

FDA Submissions

UNKNOWN; ORIG1AP2014-01-27
LABELING; LabelingSUPPL3AP2019-11-14STANDARD

Submissions Property Types

ORIG1Null1
SUPPL3Null15

TE Codes

001PrescriptionAP

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202747
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/27\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/14\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-14
        )

)

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