ANDA 074441

ATHENEX INC

FDA Drug Application

Application #074441

Application Sponsors

ANDA 074441

ATHENEX INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.25MG/ML

0

BUMETANIDE

BUMETANIDE

FDA Submissions

	ORIG	1	AP	1995-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1996-09-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-07-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-08-28
LABELING; Labeling	SUPPL	8	AP	1998-11-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-04-03
LABELING; Labeling	SUPPL	12	AP	2010-03-08

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	7

TE Codes

001

Prescription

AP

CDER Filings

ATHENEX INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74441
            [companyName] => ATHENEX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BUMETANIDE","activeIngredients":"BUMETANIDE","strength":"0.25MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BUMETANIDE","submission":"BUMETANIDE","actionType":"0.25MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)