ANDA 075774

PERRIGO ISRAEL

FDA Drug Application

Application #075774

Documents

• Review: 2005-07-22

Application Sponsors

ANDA 075774

PERRIGO ISRAEL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

EQ 12% BASE

0

AMMONIUM LACTATE

AMMONIUM LACTATE

FDA Submissions

	ORIG	1	AP	2002-05-01
LABELING; Labeling	SUPPL	2	AP	2002-12-26
LABELING; Labeling	SUPPL	4	AP	2009-06-09

Submissions Property Types

SUPPL

1

Null

0

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO ISRAEL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75774
            [companyName] => PERRIGO ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMMONIUM LACTATE","activeIngredients":"AMMONIUM LACTATE","strength":"EQ 12% BASE","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMMONIUM LACTATE","submission":"AMMONIUM LACTATE","actionType":"EQ 12% BASE","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)