ANDA 086863

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #086863

Application Sponsors

ANDA 086863

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

CONCENTRATE;ORAL

100MG/ML

0

CHLORPROMAZINE HYDROCHLORIDE

CHLORPROMAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1980-11-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-07-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-08-13
LABELING; Labeling	SUPPL	13	AP	1989-11-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1991-10-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1997-09-25
LABELING; Labeling	SUPPL	19	AP	1999-09-02
LABELING; Labeling	SUPPL	20	AP	1999-12-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-10-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-01-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-04-30
LABELING; Labeling	SUPPL	28	AP	2015-11-03
LABELING; Labeling	SUPPL	29	AP	2017-02-23	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	28	Null	7
SUPPL	29	Null	15

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86863
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLORPROMAZINE HYDROCHLORIDE","activeIngredients":"CHLORPROMAZINE HYDROCHLORIDE","strength":"100MG\/ML","dosageForm":"CONCENTRATE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLORPROMAZINE HYDROCHLORIDE","submission":"CHLORPROMAZINE HYDROCHLORIDE","actionType":"100MG\/ML","submissionClassification":"CONCENTRATE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)