ANDA 076925

L PERRIGO CO

FDA Drug Application

Application #076925

Application Sponsors

ANDA 076925

L PERRIGO CO

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

100MG/5ML

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	2004-09-23
LABELING; Labeling	SUPPL	10	AP	2006-03-22
LABELING; Labeling	SUPPL	11	AP	2006-07-03
LABELING; Labeling	SUPPL	20	AP	2008-09-04
LABELING; Labeling	SUPPL	29	AP	2013-08-13
LABELING; Labeling	SUPPL	33	AP	2016-05-09	STANDARD
LABELING; Labeling	SUPPL	36	AP	2017-04-18	STANDARD
LABELING; Labeling	SUPPL	41	AP	2019-07-22	STANDARD
LABELING; Labeling	SUPPL	47	AP	2021-04-28	STANDARD

Submissions Property Types

SUPPL	29	Null	7
SUPPL	33	Null	15
SUPPL	36	Null	7
SUPPL	41	Null	7
SUPPL	47	Null	15

TE Codes

001

Prescription

AB

CDER Filings

L PERRIGO CO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76925
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG\/5ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"100MG\/5ML","submissionClassification":"SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)