ANDA 075529

PERRIGO PHARMA INTL

FDA Drug Application

Application #075529

Documents

• Letter: 2000-02-22
• Review: 2001-06-07

Application Sponsors

ANDA 075529

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

GEL;TOPICAL

0.025%

0

TRETINOIN

TRETINOIN

FDA Submissions

	ORIG	1	AP	2000-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2001-02-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-08-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-07-11
LABELING; Labeling	SUPPL	8	AP	2007-02-21
LABELING; Labeling	SUPPL	10	AP	2007-04-20

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

TE Codes

001

Prescription

AB

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75529
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRETINOIN","activeIngredients":"TRETINOIN","strength":"0.025%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRETINOIN","submission":"TRETINOIN","actionType":"0.025%","submissionClassification":"GEL;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)