NDA 018579

AM REGENT

FDA Drug Application

Application #018579

Documents

• Label: 2011-08-16
• Letter: 2022-05-05
• Label: 2022-05-06

Application Sponsors

NDA 018579

AM REGENT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

FUROSEMIDE

FUROSEMIDE

FDA Submissions

	ORIG	1	AP	1983-11-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-02-14
LABELING; Labeling	SUPPL	6	AP	1988-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1989-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1989-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-08-15
LABELING; Labeling	SUPPL	10	AP	1991-08-22
LABELING; Labeling	SUPPL	11	AP	1992-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1992-12-29
LABELING; Labeling	SUPPL	13	AP	1993-06-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1997-07-08
LABELING; Labeling	SUPPL	16	AP	1997-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2000-12-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2002-07-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2002-06-27
LABELING; Labeling	SUPPL	22	AP	2002-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2002-06-27
LABELING; Labeling	SUPPL	29	AP	2011-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2014-06-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2022-03-30	N/A

Submissions Property Types

SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	15	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	29	Null	15
SUPPL	30	Null	0
SUPPL	33	Null	15

CDER Filings

AM REGENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18579
            [companyName] => AM REGENT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"03\/30\/2022","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/018579Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2022","submission":"SUPPL-33","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/018579Orig1s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2011","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/018579s029lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"FUROSEMIDE","submission":"FUROSEMIDE","actionType":"10MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-03-30
        )

)