SEPTODONT FDA Approval ANDA 077250

ANDA 077250

SEPTODONT

FDA Drug Application

Application #077250

Application Sponsors

ANDA 077250SEPTODONT

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION0.5%;0.0091MG/ML0BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

FDA Submissions

ORIG1AP2006-09-27
LABELING; LabelingSUPPL2AP2007-11-29
LABELING; LabelingSUPPL9AP2013-03-28STANDARD
LABELING; LabelingSUPPL10AP2015-08-27STANDARD

Submissions Property Types

ORIG1Null1
SUPPL9Null15
SUPPL10Null15

CDER Filings

SEPTODONT
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77250
            [companyName] => SEPTODONT
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE","activeIngredients":"BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE","strength":"0.5%;0.0091MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE","submission":"BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE","actionType":"0.5%;0.0091MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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