ANDA 040911

SEPTODONT INC

FDA Drug Application

Application #040911

Application Sponsors

ANDA 040911

SEPTODONT INC

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

5%

0

LIDOCAINE

LIDOCAINE

FDA Submissions

	ORIG	1	AP	2011-05-23
LABELING; Labeling	SUPPL	5	AP	2018-11-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2018-11-02	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	7	Null	7

TE Codes

001

Prescription

AT

CDER Filings

SEPTODONT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40911
            [companyName] => SEPTODONT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE","activeIngredients":"LIDOCAINE","strength":"5%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE","submission":"LIDOCAINE","actionType":"5%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)