ANDA 075265

PERRIGO PHARMA INTL

FDA Drug Application

Application #075265

Documents

• Label: 1998-12-24
• Review: 2001-08-24
• Letter: 1998-12-24

Application Sponsors

ANDA 075265

PERRIGO PHARMA INTL

Marketing Status

• Prescription: 001

Application Products

001

CREAM;TOPICAL

0.05%

0

TRETINOIN

TRETINOIN

FDA Submissions

	ORIG	1	AP	1998-12-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-12-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-02-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2001-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2001-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-10-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-10-24
LABELING; Labeling	SUPPL	24	AP	2007-02-21
LABELING; Labeling	SUPPL	26	AP	2007-04-20

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

TE Codes

001

Prescription

AB1

CDER Filings

PERRIGO PHARMA INTL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75265
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRETINOIN","activeIngredients":"TRETINOIN","strength":"0.05%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/24\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/98\\\/75265_Tretinoin_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TRETINOIN","submission":"TRETINOIN","actionType":"0.05%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-12-24
        )

)