ANDA 072299

CONTRACT PHARMACAL

FDA Drug Application

Application #072299

Application Sponsors

ANDA 072299

CONTRACT PHARMACAL

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1988-07-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-09-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-09-23
BIOEQUIV; Bioequivalence	SUPPL	4	AP	1989-12-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1993-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1994-06-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1996-07-23
LABELING; Labeling	SUPPL	10	AP	1999-12-01
LABELING; Labeling	SUPPL	12	AP	2004-09-29
LABELING; Labeling	SUPPL	14	AP	2006-03-31

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72299
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)