ANDA 076409

SUN PHARM INDS LTD

FDA Drug Application

Application #076409

Documents

• Other Important Information from FDA: 2007-05-09

Application Sponsors

ANDA 076409

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	50MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
002	TABLET;ORAL	100MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
003	TABLET;ORAL	150MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
004	TABLET;ORAL	200MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE
005	TABLET;ORAL	250MG	0	NEFAZODONE HYDROCHLORIDE	NEFAZODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2003-09-16
LABELING; Labeling	SUPPL	2	AP	2008-01-15
LABELING; Labeling	SUPPL	4	AP	2008-11-13
LABELING; Labeling	SUPPL	5	AP	2009-06-22

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76409
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NEFAZODONE HYDROCHLORIDE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NEFAZODONE HYDROCHLORIDE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)