NDA 018197

BASF

FDA Drug Application

Application #018197

Application Sponsors

NDA 018197

BASF

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	400MG	0	IBU	IBUPROFEN
002	TABLET;ORAL	600MG	0	RUFEN	IBUPROFEN

FDA Submissions

	ORIG	1	AP	1981-05-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-05-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1986-01-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1986-07-01
LABELING; Labeling	SUPPL	22	AP	1989-01-17
LABELING; Labeling	SUPPL	23	AP	1988-10-28
LABELING; Labeling	SUPPL	24	AP	1989-01-19
LABELING; Labeling	SUPPL	26	AP	1989-10-25
LABELING; Labeling	SUPPL	27	AP	1991-10-09
LABELING; Labeling	SUPPL	29	AP	1995-01-05
LABELING; Labeling	SUPPL	30	AP	1995-03-06

Submissions Property Types

ORIG	1	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0

CDER Filings

BASF

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18197
            [companyName] => BASF
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBU","activeIngredients":"IBUPROFEN","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RUFEN","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBU","submission":"IBUPROFEN","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RUFEN","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)