ANDA 078594

PERRIGO CO

FDA Drug Application

Application #078594

Application Sponsors

ANDA 078594

PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

1%

0

CICLOPIROX

CICLOPIROX

FDA Submissions

	ORIG	1	AP	2010-02-16
LABELING; Labeling	SUPPL	5	AP	2015-10-14	STANDARD

Submissions Property Types

ORIG	1	Null	3
SUPPL	5	Null	15

TE Codes

001

Prescription

AT

CDER Filings

PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78594
            [companyName] => PERRIGO CO
            [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
        )

)