ANDA 080600

HIKMA PHARMS

FDA Drug Application

Application #080600

Documents

• Review: 2007-04-02

Application Sponsors

ANDA 080600

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

1MG

0

FOLIC ACID

FOLIC ACID

FDA Submissions

	ORIG	1	AP	1972-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1983-03-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1987-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1987-10-01
LABELING; Labeling	SUPPL	14	AP	1989-07-17
LABELING; Labeling	SUPPL	19	AP	1993-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1993-07-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1994-07-29
LABELING; Labeling	SUPPL	22	AP	1994-07-29
LABELING; Labeling	SUPPL	23	AP	1995-04-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1997-06-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1997-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1997-12-10
LABELING; Labeling	SUPPL	27	AP	1997-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1998-10-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1999-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1999-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2000-02-17

Submissions Property Types

SUPPL	6	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0

TE Codes

001

Prescription

AA

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 80600
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOLIC ACID","activeIngredients":"FOLIC ACID","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOLIC ACID","submission":"FOLIC ACID","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)