ANDA 077973

SYNTHON PHARMS

FDA Drug Application

Application #077973

Documents

• Label: 2009-07-24
• Letter: 2009-07-09

Application Sponsors

ANDA 077973

SYNTHON PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

BICALUTAMIDE

BICALUTAMIDE

FDA Submissions

	ORIG	1	AP	2009-07-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2011-01-07
LABELING; Labeling	SUPPL	3	AP	2011-04-26

Submissions Property Types

SUPPL	2	Null	8
SUPPL	3	Null	8

CDER Filings

SYNTHON PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77973
            [companyName] => SYNTHON PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"BICALUTAMIDE","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"07\/06\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/077973s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"BICALUTAMIDE","submission":"BICALUTAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-07-06
        )

)