ANDA 080925

SEPTODONT INC

FDA Drug Application

Application #080925

Application Sponsors

ANDA 080925

SEPTODONT INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

3%

0

ISOCAINE HYDROCHLORIDE

MEPIVACAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1972-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-08-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-06-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1984-10-10
LABELING; Labeling	SUPPL	12	AP	1983-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-05-16
LABELING; Labeling	SUPPL	14	AP	1991-05-16
LABELING; Labeling	SUPPL	16	AP	1990-09-20
LABELING; Labeling	SUPPL	17	AP	1992-05-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1993-01-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-03-11
LABELING; Labeling	SUPPL	22	AP	1993-04-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-08-02

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0

CDER Filings

SEPTODONT INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80925
            [companyName] => SEPTODONT INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOCAINE HYDROCHLORIDE","activeIngredients":"MEPIVACAINE HYDROCHLORIDE","strength":"3%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOCAINE HYDROCHLORIDE","submission":"MEPIVACAINE HYDROCHLORIDE","actionType":"3%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)