ANDA 071340

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #071340

Application Sponsors

ANDA 071340

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

EQ 5MG BASE/5ML

0

METOCLOPRAMIDE HYDROCHLORIDE

METOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1988-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-09-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-09-27
LABELING; Labeling	SUPPL	5	AP	1990-06-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1991-04-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1991-09-27
LABELING; Labeling	SUPPL	9	AP	1993-03-29
LABELING; Labeling	SUPPL	10	AP	1993-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-09-15
LABELING; Labeling	SUPPL	13	AP	1996-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-05-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1998-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-10-21
LABELING; Labeling	SUPPL	18	AP	2000-05-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-07-31
LABELING; Labeling	SUPPL	20	AP	2001-07-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-10-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2002-10-30
LABELING; Labeling	SUPPL	23	AP	2003-04-11

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71340
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOCLOPRAMIDE HYDROCHLORIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METOCLOPRAMIDE HYDROCHLORIDE","submission":"METOCLOPRAMIDE HYDROCHLORIDE","actionType":"EQ 5MG BASE\/5ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)