ANDA 074782

CONTRACT PHARMACAL

FDA Drug Application

Application #074782

Documents

• Letter: 1998-07-06
• Review: 1998-07-06

Application Sponsors

ANDA 074782

CONTRACT PHARMACAL

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

200MG

0

IBUPROFEN

IBUPROFEN

FDA Submissions

	ORIG	1	AP	1998-07-06
LABELING; Labeling	SUPPL	2	AP	1999-12-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-10-27
LABELING; Labeling	SUPPL	4	AP	2006-03-22

Submissions Property Types

SUPPL

3

Null

0

CDER Filings

CONTRACT PHARMACAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74782
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)