ANDA 074931

CONTRACT PHARMACAL

FDA Drug Application

Application #074931

Documents

• Letter: 1998-07-20
• Label: 2004-06-07
• Review: 2003-08-04

Application Sponsors

ANDA 074931

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1998-07-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-08-16
LABELING; Labeling	SUPPL	5	AP	2000-07-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-05-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-07-24

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74931
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/20\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/98\\\/74931_Ibuprofen_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1998-07-20
        )

)