ANDA 087736

HIKMA INTL PHARMS

FDA Drug Application

Application #087736

Application Sponsors

ANDA 087736

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

CHLOROTHIAZIDE

CHLOROTHIAZIDE

FDA Submissions

	ORIG	1	AP	1982-07-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-11-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1991-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1991-07-24
LABELING; Labeling	SUPPL	11	AP	1992-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-07-24
BIOEQUIV; Bioequivalence	SUPPL	13	AP	1990-11-14
LABELING; Labeling	SUPPL	14	AP	1990-05-04
LABELING; Labeling	SUPPL	17	AP	1995-05-24
LABELING; Labeling	SUPPL	18	AP	1996-09-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-06-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

Accessdata Error

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87736
            [companyName] => Accessdata Error
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)