ANDA 065123

PERRIGO ISRAEL

FDA Drug Application

Application #065123

Documents

• Review: 2007-04-02

Application Sponsors

ANDA 065123

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

OINTMENT;TOPICAL

2%

0

MUPIROCIN

MUPIROCIN

FDA Submissions

	ORIG	1	AP	2003-11-07
LABELING; Labeling	SUPPL	2	AP	2005-11-28
LABELING; Labeling	SUPPL	4	AP	2008-07-18
LABELING; Labeling	SUPPL	5	AP	2008-04-14
LABELING; Labeling	SUPPL	13	AP	2016-12-06	STANDARD
LABELING; Labeling	SUPPL	14	AP	2016-12-06	STANDARD
LABELING; Labeling	SUPPL	15	AP	2016-12-06	STANDARD

Submissions Property Types

SUPPL	13	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	15

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65123
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MUPIROCIN","activeIngredients":"MUPIROCIN","strength":"2%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MUPIROCIN","submission":"MUPIROCIN","actionType":"2%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)