ANDA 071200

NESHER PHARMS

FDA Drug Application

Application #071200

Application Sponsors

ANDA 071200

NESHER PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

EQ 150MG BASE

0

DISOPYRAMIDE PHOSPHATE

DISOPYRAMIDE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1987-12-15
LABELING; Labeling	SUPPL	2	AP	1990-02-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1990-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1991-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1991-12-09
LABELING; Labeling	SUPPL	8	AP	1991-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-02-25
LABELING; Labeling	SUPPL	10	AP	1992-04-30
LABELING; Labeling	SUPPL	11	AP	1992-10-07
LABELING; Labeling	SUPPL	12	AP	1993-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1998-10-06
LABELING; Labeling	SUPPL	14	AP	1996-11-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1999-04-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-10-26
LABELING; Labeling	SUPPL	17	AP	2000-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-06-12
LABELING; Labeling	SUPPL	23	AP	2002-06-12

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71200
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISOPYRAMIDE PHOSPHATE","activeIngredients":"DISOPYRAMIDE PHOSPHATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISOPYRAMIDE PHOSPHATE","submission":"DISOPYRAMIDE PHOSPHATE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)