ANDA 078837

PERRIGO ISRAEL

FDA Drug Application

Application #078837

Application Sponsors

ANDA 078837

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

5%

0

IMIQUIMOD

IMIQUIMOD

FDA Submissions

	ORIG	1	AP	2010-09-07
LABELING; Labeling	SUPPL	2	AP	2013-07-31

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78837
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMIQUIMOD","activeIngredients":"IMIQUIMOD","strength":"5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IMIQUIMOD","submission":"IMIQUIMOD","actionType":"5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)