ANDA 088637

INTL MEDICATION

FDA Drug Application

Application #088637

Application Sponsors

ANDA 088637

INTL MEDICATION

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

500MG/ML

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1987-01-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-09-10
LABELING; Labeling	SUPPL	6	AP	1990-01-05
LABELING; Labeling	SUPPL	7	AP	1992-03-13
LABELING; Labeling	SUPPL	8	AP	1992-06-10
LABELING; Labeling	SUPPL	9	AP	1992-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-09-19
LABELING; Labeling	SUPPL	14	AP	1999-09-22

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	1
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88637
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)