ANDA 071107

HIKMA INTL PHARMS

FDA Drug Application

Application #071107

Application Sponsors

ANDA 071107

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

15MG

0

FLURAZEPAM HYDROCHLORIDE

FLURAZEPAM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1986-12-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-10-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-08-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-08-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1988-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1988-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1988-03-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1988-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1988-07-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1988-07-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1989-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1989-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1991-05-31
LABELING; Labeling	SUPPL	20	AP	1994-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1999-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2000-11-30
LABELING; Labeling	SUPPL	25	AP	2008-08-20
LABELING; Labeling	SUPPL	27	AP	2009-08-11
LABELING; Labeling	SUPPL	28	AP	2016-11-18	STANDARD
LABELING; Labeling	SUPPL	29	AP	2016-12-16	STANDARD
LABELING; Labeling	SUPPL	30	AP	2019-02-22	STANDARD
LABELING; Labeling	SUPPL	31	AP	2021-02-08	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
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	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	7
SUPPL	28	Null	7
SUPPL	29	Null	7
SUPPL	30	Null	7
SUPPL	31	Null	15

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71107
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURAZEPAM HYDROCHLORIDE","activeIngredients":"FLURAZEPAM HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLURAZEPAM HYDROCHLORIDE","submission":"FLURAZEPAM HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)