ANDA 071666

PLIVA

FDA Drug Application

Application #071666

Application Sponsors

ANDA 071666

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

400MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1987-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1988-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1988-01-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1988-07-05
LABELING; Labeling	SUPPL	8	AP	1989-02-01
BIOEQUIV; Bioequivalence	SUPPL	12	AP	1989-12-07
LABELING; Labeling	SUPPL	13	AP	1992-01-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1994-05-11
LABELING; Labeling	SUPPL	17	AP	2016-05-09	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	15

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71666
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)