Documents
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001 | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SERZONE | NEFAZODONE HYDROCHLORIDE |
002 | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SERZONE | NEFAZODONE HYDROCHLORIDE |
003 | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SERZONE | NEFAZODONE HYDROCHLORIDE |
004 | TABLET;ORAL | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SERZONE | NEFAZODONE HYDROCHLORIDE |
005 | TABLET;ORAL | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SERZONE | NEFAZODONE HYDROCHLORIDE |
006 | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | 1 | SERZONE | NEFAZODONE HYDROCHLORIDE |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
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[ApplNo] => 20152
[companyName] => BRISTOL MYERS SQUIBB
[docInserts] => ["",""]
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[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
)
)