ANDA 070088

BASF

FDA Drug Application

Application #070088

Documents

• Other: 2018-05-01

Application Sponsors

ANDA 070088

BASF

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

600MG

0

IBU

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1985-02-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1985-04-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1986-01-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-03-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-03-24
LABELING; Labeling	SUPPL	7	AP	1988-02-08
LABELING; Labeling	SUPPL	8	AP	1988-10-07

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0

CDER Filings

BASF

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70088
            [companyName] => BASF
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBU","activeIngredients":"IBUPROFEN","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBU","submission":"IBUPROFEN","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)