ANDA 076419

PERRIGO ISRAEL

FDA Drug Application

Application #076419

Documents

• Review: 2007-04-02

Application Sponsors

ANDA 076419

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

SHAMPOO;TOPICAL

2%

0

KETOCONAZOLE

KETOCONAZOLE

FDA Submissions

	ORIG	1	AP	2004-01-07
LABELING; Labeling	SUPPL	4	AP	2008-02-01
LABELING; Labeling	SUPPL	10	AP	2011-02-04
LABELING; Labeling	SUPPL	12	AP	2013-03-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2015-08-31	STANDARD

Submissions Property Types

SUPPL	12	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76419
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOCONAZOLE","activeIngredients":"KETOCONAZOLE","strength":"2%","dosageForm":"SHAMPOO;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOCONAZOLE","submission":"KETOCONAZOLE","actionType":"2%","submissionClassification":"SHAMPOO;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)