ANDA 080850

AM REGENT

FDA Drug Application

Application #080850

Application Sponsors

ANDA 080850

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1%

0

LIDOCAINE HYDROCHLORIDE

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1972-06-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-07-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-02-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1992-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1992-04-06
LABELING; Labeling	SUPPL	17	AP	1991-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1993-06-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-08-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-08-03
LABELING; Labeling	SUPPL	22	AP	2000-10-31
LABELING; Labeling	SUPPL	28	AP	2010-02-26
LABELING; Labeling	SUPPL	29	AP	2010-04-09

Submissions Property Types

SUPPL	7	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	28	Null	7
SUPPL	29	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80850
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"1%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)