ANDA 062591

ACS DOBFAR

FDA Drug Application

Application #062591

Application Sponsors

ANDA 062591

ACS DOBFAR

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	EQ 750MG BASE/VIAL	0	KEFUROX	CEFUROXIME SODIUM
002	INJECTABLE;INJECTION	EQ 1.5GM BASE/VIAL	0	KEFUROX	CEFUROXIME SODIUM
003	INJECTABLE;INJECTION	EQ 7.5GM BASE/VIAL	0	KEFUROX	CEFUROXIME SODIUM

FDA Submissions

	ORIG	1	AP	1986-01-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-06-12
LABELING; Labeling	SUPPL	11	AP	1994-02-03
LABELING; Labeling	SUPPL	15	AP	1991-12-10
LABELING; Labeling	SUPPL	16	AP	1992-06-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1997-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1997-01-13
LABELING; Labeling	SUPPL	20	AP	1997-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1996-08-15
LABELING; Labeling	SUPPL	23	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1999-01-20
LABELING; Labeling	SUPPL	26	AP	1999-01-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2001-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2001-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2001-01-22
LABELING; Labeling	SUPPL	32	AP	2001-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2001-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-09-04
LABELING; Labeling	SUPPL	35	AP	2002-11-12
LABELING; Labeling	SUPPL	36	AP	2002-11-12
LABELING; Labeling	SUPPL	37	AP	2002-11-12
LABELING; Labeling	SUPPL	38	AP	2002-11-12

Submissions Property Types

SUPPL	10	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	1
SUPPL	33	Null	0
SUPPL	34	Null	0

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62591
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)