ANDA 075589

PERRIGO PHARMA INTL

FDA Drug Application

Application #075589

Application Sponsors

ANDA 075589

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.01%

0

TRETINOIN

TRETINOIN

FDA Submissions

	ORIG	1	AP	2002-06-11
LABELING; Labeling	SUPPL	4	AP	2007-02-21
LABELING; Labeling	SUPPL	6	AP	2007-05-25

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75589
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRETINOIN","activeIngredients":"TRETINOIN","strength":"0.01%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRETINOIN","submission":"TRETINOIN","actionType":"0.01%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)