ANDA 077250

SEPTODONT

FDA Drug Application

Application #077250

Application Sponsors

ANDA 077250

SEPTODONT

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.5%;0.0091MG/ML

0

BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE

BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

FDA Submissions

	ORIG	1	AP	2006-09-27
LABELING; Labeling	SUPPL	2	AP	2007-11-29
LABELING; Labeling	SUPPL	9	AP	2013-03-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	2015-08-27	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	9	Null	15
SUPPL	10	Null	15

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
        )

)