ANDA 078959

SEPTODONT INC

FDA Drug Application

Application #078959

Application Sponsors

ANDA 078959

SEPTODONT INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.005MG/ML;4%

0

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2011-08-30
LABELING; Labeling	SUPPL	6	AP	2019-11-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SEPTODONT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78959
            [companyName] => SEPTODONT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE","activeIngredients":"EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE","strength":"0.005MG\/ML;4%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE","submission":"EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE","actionType":"0.005MG\/ML;4%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)