BAXTER HLTHCARE CORP FDA Approval ANDA 076051

ANDA 076051

BAXTER HLTHCARE CORP

FDA Drug Application

Application #076051

Application Sponsors

ANDA 076051BAXTER HLTHCARE CORP

Marketing Status

Discontinued001

Application Products

001INJECTABLE;INJECTION5MG/ML0LABETALOL HYDROCHLORIDELABETALOL HYDROCHLORIDE

FDA Submissions

ORIG1AP2002-07-05

TE Codes

001PrescriptionAP

CDER Filings

BAXTER HLTHCARE CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76051
            [companyName] => BAXTER HLTHCARE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"LABETALOL HYDROCHLORIDE","activeIngredients":"LABETALOL HYDROCHLORIDE","strength":"5MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LABETALOL HYDROCHLORIDE","submission":"LABETALOL HYDROCHLORIDE","actionType":"5MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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