ANDA 080776

HIKMA INTL PHARMS

FDA Drug Application

Application #080776

Application Sponsors

ANDA 080776

HIKMA INTL PHARMS

Marketing Status

• Prescription: 002

Application Products

002

TABLET;ORAL

25MG

0

CORTISONE ACETATE

CORTISONE ACETATE

FDA Submissions

	ORIG	1	AP	1972-06-13
LABELING; Labeling	SUPPL	13	AP	1988-02-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1988-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1988-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1988-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1988-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1988-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1988-08-22
LABELING; Labeling	SUPPL	22	AP	1988-08-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1993-08-24
LABELING; Labeling	SUPPL	28	AP	1994-05-05
LABELING; Labeling	SUPPL	29	AP	1995-02-15
LABELING; Labeling	SUPPL	30	AP	1996-04-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1998-11-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2000-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-03-22

Submissions Property Types

SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80776
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)