ANDA 071773

PLIVA

FDA Drug Application

Application #071773

Application Sponsors

ANDA 071773

PLIVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPRIN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1987-07-16
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	7	AP	1994-05-11

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	7	Null	0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71773
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPRIN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPRIN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)