ANDA 075217

L PERRIGO CO

FDA Drug Application

Application #075217

Documents

• Letter: 1998-12-16
• Label: 1998-12-16
• Review: 1998-12-16

Application Sponsors

ANDA 075217

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

SUSPENSION/DROPS;ORAL

40MG/ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1998-12-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-05-24
LABELING; Labeling	SUPPL	3	AP	2000-05-24
LABELING; Labeling	SUPPL	4	AP	2000-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2001-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2001-08-21
LABELING; Labeling	SUPPL	9	AP	2003-05-22
LABELING; Labeling	SUPPL	26	AP	2006-03-22
LABELING; Labeling	SUPPL	38	AP	2011-05-24

Submissions Property Types

SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75217
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"40MG\/ML","dosageForm":"SUSPENSION\/DROPS;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/16\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/75-217_Ibuprofen_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"40MG\/ML","submissionClassification":"SUSPENSION\/DROPS;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-12-16
        )

)