ANDA 086156

TARO

FDA Drug Application

Application #086156

Application Sponsors

ANDA 086156

TARO

Marketing Status

• Discontinued: 001

Application Products

001

OINTMENT;TOPICAL

0.2%

0

NITROFURAZONE

NITROFURAZONE

FDA Submissions

	ORIG	1	AP	1978-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1982-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-08-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1984-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-11-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-08-08
LABELING; Labeling	SUPPL	16	AP	1989-02-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1989-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1989-05-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1989-08-18
LABELING; Labeling	SUPPL	20	AP	1992-07-28
LABELING; Labeling	SUPPL	21	AP	1992-09-14

Submissions Property Types

SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

TARO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86156
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROFURAZONE","activeIngredients":"NITROFURAZONE","strength":"0.2%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROFURAZONE","submission":"NITROFURAZONE","actionType":"0.2%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)