NDA 020152

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #020152

Documents

• Letter: 1998-03-31
• Letter: 2002-01-08
• Letter: 2003-05-30
• Letter: 2002-06-20
• Letter: 2004-06-01
• Letter: 2005-01-13
• Label: 2005-01-13
• Review: 2007-05-09
• Review: 2007-05-09
• Letter: 2001-03-21
• Letter: 2001-12-04
• Review: 2007-07-06
• Review: 2007-05-09
• Review: 2005-01-06
• Review: 2007-07-06
• Other Important Information from FDA: 2007-05-09
• Pediatric Medical Review: 1900-01-01
• Pediatric Written Request: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 020152

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

001	TABLET;ORAL	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SERZONE	NEFAZODONE HYDROCHLORIDE
002	TABLET;ORAL	100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SERZONE	NEFAZODONE HYDROCHLORIDE
003	TABLET;ORAL	150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SERZONE	NEFAZODONE HYDROCHLORIDE
004	TABLET;ORAL	200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SERZONE	NEFAZODONE HYDROCHLORIDE
005	TABLET;ORAL	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SERZONE	NEFAZODONE HYDROCHLORIDE
006	TABLET;ORAL	300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	SERZONE	NEFAZODONE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1994-12-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1996-03-20	STANDARD
LABELING; Labeling	SUPPL	3	AP	1996-06-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1996-03-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-02-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2000-07-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-01-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1996-12-02	STANDARD
LABELING; Labeling	SUPPL	9	AP	1997-05-05	STANDARD
LABELING; Labeling	SUPPL	10	AP	1997-05-05	STANDARD
LABELING; Labeling	SUPPL	11	AP	1998-03-31	STANDARD
LABELING; Labeling	SUPPL	12	AP	1997-08-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1999-01-27	STANDARD
LABELING; Labeling	SUPPL	14	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	15	AP	2000-06-01	STANDARD
LABELING; Labeling	SUPPL	16	AP	2000-06-01	STANDARD
LABELING; Labeling	SUPPL	17	AP	2000-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1999-09-23	STANDARD
LABELING; Labeling	SUPPL	19	AP	2000-06-01	STANDARD
LABELING; Labeling	SUPPL	20	AP	1999-09-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1999-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-04-10	STANDARD
LABELING; Labeling	SUPPL	23	AP	2000-06-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-11-09	STANDARD
LABELING; Labeling	SUPPL	25	AP	2001-01-23	STANDARD
LABELING; Labeling	SUPPL	26	AP	2001-03-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2002-03-11	STANDARD
LABELING; Labeling	SUPPL	28	AP	2001-12-04	STANDARD
LABELING; Labeling	SUPPL	29	AP	2002-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2002-04-23	STANDARD
LABELING; Labeling	SUPPL	31	AP	2003-05-05	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2009-03-13	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2002-06-20	STANDARD
LABELING; Labeling	SUPPL	34	AP	2004-05-27	STANDARD
LABELING; Labeling	SUPPL	35	AP	2005-01-12	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	13	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	8

CDER Filings

BRISTOL MYERS SQUIBB

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(
    [0] => Array
        (
            [ApplNo] => 20152
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"SERZONE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SERZONE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SERZONE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SERZONE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SERZONE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"SERZONE","activeIngredients":"NEFAZODONE HYDROCHLORIDE","strength":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/12\/2005","submission":"SUPPL-35","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/20152s035lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SERZONE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SERZONE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SERZONE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SERZONE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SERZONE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"SERZONE","submission":"NEFAZODONE HYDROCHLORIDE","actionType":"300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2005-01-12
        )

)