ANDA 075367

L PERRIGO CO

FDA Drug Application

Application #075367

Application Sponsors

ANDA 075367

L PERRIGO CO

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

100MG

0

JUNIOR STRENGTH IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1999-04-22
LABELING; Labeling	SUPPL	2	AP	2001-04-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-08-21
LABELING; Labeling	SUPPL	18	AP	2006-03-17

Submissions Property Types

SUPPL

3

Null

0

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75367
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"JUNIOR STRENGTH IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"JUNIOR STRENGTH IBUPROFEN","submission":"IBUPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)