ANDA 070745

BASF

FDA Drug Application

Application #070745

Application Sponsors

ANDA 070745

BASF

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

800MG

0

IBU

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1986-07-23
LABELING; Labeling	SUPPL	2	AP	1988-03-01
LABELING; Labeling	SUPPL	3	AP	1988-10-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1989-01-27
LABELING; Labeling	SUPPL	5	AP	1989-01-10
LABELING; Labeling	SUPPL	6	AP	1989-06-08
LABELING; Labeling	SUPPL	7	AP	1989-10-27
LABELING; Labeling	SUPPL	8	AP	1991-08-06
LABELING; Labeling	SUPPL	9	AP	1991-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1994-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1994-09-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1995-08-11
LABELING; Labeling	SUPPL	14	AP	1995-02-15
LABELING; Labeling	SUPPL	15	AP	1995-02-27

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0

CDER Filings

BASF

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70745
            [companyName] => BASF
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBU","activeIngredients":"IBUPROFEN","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBU","submission":"IBUPROFEN","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)