ANDA 074586

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074586

Documents

• Review: 2005-07-22

Application Sponsors

ANDA 074586

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

CREAM, SUPPOSITORY;TOPICAL, VAGINAL

2%,100MG

0

M-ZOLE 7 DUAL PACK

MICONAZOLE NITRATE

FDA Submissions

	ORIG	1	AP	1997-07-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-04-30
LABELING; Labeling	SUPPL	3	AP	2000-02-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-12-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2002-01-08
LABELING; Labeling	SUPPL	6	AP	2002-11-21

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74586
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"M-ZOLE 7 DUAL PACK","activeIngredients":"MICONAZOLE NITRATE","strength":"2%,100MG","dosageForm":"CREAM, SUPPOSITORY;TOPICAL, VAGINAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"M-ZOLE 7 DUAL PACK","submission":"MICONAZOLE NITRATE","actionType":"2%,100MG","submissionClassification":"CREAM, SUPPOSITORY;TOPICAL, VAGINAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)