ANDA 084048

SEPTODONT

FDA Drug Application

Application #084048

Application Sponsors

ANDA 084048

SEPTODONT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	0.01MG/ML;2%	0	OCTOCAINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
002	INJECTABLE;INJECTION	0.02MG/ML;2%	0	OCTOCAINE	EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1980-09-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1983-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1984-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1990-06-29
LABELING; Labeling	SUPPL	17	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1993-01-26
LABELING; Labeling	SUPPL	20	AP	1992-01-14
LABELING; Labeling	SUPPL	21	AP	1992-01-14
LABELING; Labeling	SUPPL	22	AP	1998-04-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1999-08-02

Submissions Property Types

SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0

CDER Filings

SEPTODONT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84048
            [companyName] => SEPTODONT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OCTOCAINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.01MG\/ML;2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OCTOCAINE","activeIngredients":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","strength":"0.02MG\/ML;2%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OCTOCAINE","submission":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","actionType":"0.01MG\/ML;2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OCTOCAINE","submission":"EPINEPHRINE; LIDOCAINE HYDROCHLORIDE","actionType":"0.02MG\/ML;2%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)