ANDA 079235

SEPTODONT INC

FDA Drug Application

Application #079235

Documents

• Letter: 2010-10-04

Application Sponsors

ANDA 079235

SEPTODONT INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

4%

0

PRILOCAINE HYDROCHLORIDE

PRILOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-09-29
LABELING; Labeling	SUPPL	5	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7

CDER Filings

SEPTODONT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79235
            [companyName] => SEPTODONT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PRILOCAINE HYDROCHLORIDE","activeIngredients":"PRILOCAINE HYDROCHLORIDE","strength":"4%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"PRILOCAINE HYDROCHLORIDE","submission":"PRILOCAINE HYDROCHLORIDE","actionType":"4%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)