NDA 040024

AM REGENT

FDA Drug Application

Application #040024

Documents

• Label: 2009-09-22

Application Sponsors

NDA 040024

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 50MG IRON/ML

0

DEXFERRUM

IRON DEXTRAN

FDA Submissions

UNKNOWN;	ORIG	1	AP	1996-02-23	UNKNOWN
LABELING; Labeling	SUPPL	2	AP	1998-01-29	STANDARD
LABELING; Labeling	SUPPL	3	AP	1998-01-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1998-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-09-25
LABELING; Labeling	SUPPL	7	AP	1998-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-07-20
LABELING; Labeling	SUPPL	10	AP	2000-02-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2001-05-31
LABELING; Labeling	SUPPL	12	AP	2002-02-08	STANDARD
LABELING; Labeling	SUPPL	22	AP	2009-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2016-11-18	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	22	Null	7

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40024
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"DEXFERRUM","activeIngredients":"FERRIC OXYHYDROXIDE","strength":"EQ 50MG IRON\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/12\/2009","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/040024s022lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"DEXFERRUM","submission":"FERRIC OXYHYDROXIDE","actionType":"EQ 50MG IRON\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-08-12
        )

)