ANDA 084394

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #084394

Application Sponsors

ANDA 084394

ACTAVIS MID ATLANTIC

Marketing Status

• Discontinued: 001

Application Products

001

LOTION/SHAMPOO;TOPICAL

2.5%

0

SELENIUM SULFIDE

SELENIUM SULFIDE

FDA Submissions

	ORIG	1	AP	1975-05-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	1983-02-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1983-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	1983-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	46	AP	1983-01-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1984-12-14
LABELING; Labeling	SUPPL	50	AP	1989-12-19
MANUF (CMC); Manufacturing (CMC)	SUPPL	51	AP	1989-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1989-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	54	AP	1990-07-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1991-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	56	AP	1990-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	1991-01-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2001-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	2001-12-06

Submissions Property Types

SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0
SUPPL	46	Null	0
SUPPL	48	Null	0
SUPPL	51	Null	0
SUPPL	52	Null	0
SUPPL	54	Null	0
SUPPL	55	Null	0
SUPPL	56	Null	0
SUPPL	57	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 84394
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SELENIUM SULFIDE","activeIngredients":"SELENIUM SULFIDE","strength":"2.5%","dosageForm":"LOTION\/SHAMPOO;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SELENIUM SULFIDE","submission":"SELENIUM SULFIDE","actionType":"2.5%","submissionClassification":"LOTION\/SHAMPOO;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)