ANDA 075014

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #075014

Documents

• Letter: 2000-03-28
• Label: 2004-06-14
• Review: 2003-08-04

Application Sponsors

ANDA 075014

ACTAVIS MID ATLANTIC

Marketing Status

• Over-the-counter: 001

Application Products

001

LOTION;TOPICAL

1%

0

PERMETHRIN

PERMETHRIN

FDA Submissions

	ORIG	1	AP	2000-03-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-04-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-08-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2001-08-28
LABELING; Labeling	SUPPL	11	AP	2005-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2012-03-08

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	18	Null	15

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75014
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERMETHRIN","activeIngredients":"PERMETHRIN","strength":"1%","dosageForm":"LOTION;TOPICAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/28\/2000","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2000\\\/75014_Permethrin_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PERMETHRIN","submission":"PERMETHRIN","actionType":"1%","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2000-03-28
        )

)