ANDA 075588

CONTRACT PHARMACAL

FDA Drug Application

Application #075588

Documents

• Letter: 2004-06-07
• Letter: 2003-04-10
• Label: 2003-12-24
• Review: 2003-12-24

Application Sponsors

ANDA 075588

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

200MG;30MG

0

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2002-04-08
LABELING; Labeling	SUPPL	2	AP	2006-03-22

Submissions Property Types

SUPPL

1

Null

0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75588
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE","activeIngredients":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","strength":"200MG;30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/08\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/anda\\\/2002\\\/75588_Prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE","submission":"IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE","actionType":"200MG;30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2002-04-08
        )

)