ANDA 090490

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #090490

Documents

• Letter: 2009-12-03

Application Sponsors

ANDA 090490

ACTAVIS MID ATLANTIC

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

1%

0

CICLOPIROX

CICLOPIROX

FDA Submissions

	ORIG	1	AP	2009-11-24
LABELING; Labeling	SUPPL	2	AP	2013-04-30	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-04-18	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15
SUPPL	3	Null	15

TE Codes

001

Prescription

AT

CDER Filings

ACTAVIS MID ATLANTIC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90490
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CICLOPIROX","activeIngredients":"CICLOPIROX","strength":"1%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CICLOPIROX","submission":"CICLOPIROX","actionType":"1%","submissionClassification":"SHAMPOO;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)