ANDA 086578

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #086578

Application Sponsors

ANDA 086578

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

2%

0

LIDOCAINE HYDROCHLORIDE VISCOUS

LIDOCAINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1980-05-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1982-09-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1982-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1982-04-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1982-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1986-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-01-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1989-05-09
LABELING; Labeling	SUPPL	19	AP	1991-01-14
LABELING; Labeling	SUPPL	20	AP	1989-10-25
LABELING; Labeling	SUPPL	21	AP	1991-06-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1992-04-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1994-10-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1994-10-11
LABELING; Labeling	SUPPL	27	AP	1995-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1997-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2000-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2000-10-30
LABELING; Labeling	SUPPL	39	AP	2014-12-01	STANDARD
LABELING; Labeling	SUPPL	40	AP	2018-11-02	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	39	Null	7
SUPPL	40	Null	15

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86578
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIDOCAINE HYDROCHLORIDE VISCOUS","activeIngredients":"LIDOCAINE HYDROCHLORIDE","strength":"2%","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIDOCAINE HYDROCHLORIDE VISCOUS","submission":"LIDOCAINE HYDROCHLORIDE","actionType":"2%","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)