ANDA 070173

MAYNE PHARMA

FDA Drug Application

Application #070173

Application Sponsors

ANDA 070173

MAYNE PHARMA

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	EQ 100MG BASE	0	DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE
002	CAPSULE;ORAL	EQ 150MG BASE	0	DISOPYRAMIDE PHOSPHATE	DISOPYRAMIDE PHOSPHATE

FDA Submissions

	ORIG	1	AP	1985-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-10-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-04-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1991-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1991-01-28
LABELING; Labeling	SUPPL	15	AP	1991-10-02
LABELING; Labeling	SUPPL	16	AP	1992-11-24
LABELING; Labeling	SUPPL	17	AP	1996-10-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1998-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-11-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1999-03-03
LABELING; Labeling	SUPPL	22	AP	1999-07-26
LABELING; Labeling	SUPPL	23	AP	2000-09-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-09-12
LABELING; Labeling	SUPPL	25	AP	2001-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2001-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2001-04-25

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	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	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70173
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DISOPYRAMIDE PHOSPHATE","activeIngredients":"DISOPYRAMIDE PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DISOPYRAMIDE PHOSPHATE","activeIngredients":"DISOPYRAMIDE PHOSPHATE","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DISOPYRAMIDE PHOSPHATE","submission":"DISOPYRAMIDE PHOSPHATE","actionType":"EQ 100MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DISOPYRAMIDE PHOSPHATE","submission":"DISOPYRAMIDE PHOSPHATE","actionType":"EQ 150MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)