ANDA 084697

SEPTODONT INC

FDA Drug Application

Application #084697

Application Sponsors

ANDA 084697

SEPTODONT INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.05MG/ML;2%

0

ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-07-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-08-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-10-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1984-09-12
LABELING; Labeling	SUPPL	17	AP	1992-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-04-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1994-04-13
LABELING; Labeling	SUPPL	21	AP	1993-04-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1999-08-02

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0

CDER Filings

SEPTODONT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84697
            [companyName] => SEPTODONT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOCAINE HYDROCHLORIDE W\/ LEVONORDEFRIN","activeIngredients":"LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE","strength":"0.05MG\/ML;2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOCAINE HYDROCHLORIDE W\/ LEVONORDEFRIN","submission":"LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE","actionType":"0.05MG\/ML;2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)