ANDA 088636

INTL MEDICATION

FDA Drug Application

Application #088636

Application Sponsors

ANDA 088636

INTL MEDICATION

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

PROCAINAMIDE HYDROCHLORIDE

PROCAINAMIDE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1984-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1987-09-10
LABELING; Labeling	SUPPL	4	AP	1990-01-05
LABELING; Labeling	SUPPL	5	AP	1991-04-26
LABELING; Labeling	SUPPL	6	AP	1992-02-13
LABELING; Labeling	SUPPL	7	AP	1992-03-13
LABELING; Labeling	SUPPL	8	AP	1992-11-02
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1993-10-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1998-01-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-06-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-09-19
LABELING; Labeling	SUPPL	13	AP	1999-09-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2015-04-13
LABELING; Labeling	SUPPL	15	AP	2019-11-13	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	1
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	1
SUPPL	15	Null	15

TE Codes

001

Prescription

AP

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 88636
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)