B BRAUN MEDICAL INC FDA Approval ANDA 208475

ANDA 208475

B BRAUN MEDICAL INC

FDA Drug Application

Application #208475

Application Sponsors

ANDA 208475B BRAUN MEDICAL INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.005MG/ML;1.5%0LIDOCAINE HYDROCHLORIDE AND EPINEPHRINEEPINEPHRINE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-08STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

B BRAUN MEDICAL INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208475
            [companyName] => B BRAUN MEDICAL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;1.5%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/08\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-08
        )

)

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