ANDA 070470

AUROLIFE PHARMA LLC

FDA Drug Application

Application #070470

Application Sponsors

ANDA 070470

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

EQ 100MG BASE

0

DISOPYRAMIDE PHOSPHATE

DISOPYRAMIDE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1985-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-03-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-03-03
LABELING; Labeling	SUPPL	5	AP	1988-03-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1988-11-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-11-01
LABELING; Labeling	SUPPL	8	AP	1990-12-27
LABELING; Labeling	SUPPL	9	AP	1991-09-09
LABELING; Labeling	SUPPL	10	AP	1992-02-18
LABELING; Labeling	SUPPL	11	AP	1993-04-07
LABELING; Labeling	SUPPL	12	AP	1993-06-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-02-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-08-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70470
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISOPYRAMIDE PHOSPHATE","activeIngredients":"DISOPYRAMIDE PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISOPYRAMIDE PHOSPHATE","submission":"DISOPYRAMIDE PHOSPHATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)