ANDA 074444

TARO PHARMS

FDA Drug Application

Application #074444

Application Sponsors

ANDA 074444

TARO PHARMS

Marketing Status

• Over-the-counter: 001

Application Products

001

CREAM;VAGINAL

2%

0

MICONAZOLE NITRATE

MICONAZOLE NITRATE

FDA Submissions

	ORIG	1	AP	1997-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-12-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-08-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-11-27
LABELING; Labeling	SUPPL	8	AP	2005-04-08
LABELING; Labeling	SUPPL	12	AP	2006-10-05

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

TARO PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74444
            [companyName] => TARO PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MICONAZOLE NITRATE","activeIngredients":"MICONAZOLE NITRATE","strength":"2%","dosageForm":"CREAM;VAGINAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MICONAZOLE NITRATE","submission":"MICONAZOLE NITRATE","actionType":"2%","submissionClassification":"CREAM;VAGINAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)