Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020152
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERZONE NEFAZODONE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SERZONE NEFAZODONE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SERZONE NEFAZODONE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SERZONE NEFAZODONE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SERZONE NEFAZODONE HYDROCHLORIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
SERZONE NEFAZODONE HYDROCHLORIDE 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/22/1994 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/12/2005 SUPPL-35 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20152s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20152s035ltr.pdf
05/27/2004 SUPPL-34 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20152slr034ltr.pdf
06/20/2002 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s033LTR.pdf
03/13/2009 SUPPL-32 Efficacy-New Patient Population

Label is not available on this site.

05/05/2003 SUPPL-31 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20152slr031ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020152_s031_SERZONETOC.cfm
04/23/2002 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/08/2002 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20152s29ltr.pdf
12/04/2001 SUPPL-28 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20152s28ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020152_S028_SERZONE_AP.pdf
03/11/2002 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2001 SUPPL-26 Labeling Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20152S26LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-152s026_Nefazodone.cfm
01/23/2001 SUPPL-25 Labeling

Label is not available on this site.

11/09/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/01/2000 SUPPL-23 Labeling

Label is not available on this site.

04/10/2000 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

11/30/1999 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1999 SUPPL-20 Labeling

Label is not available on this site.

06/01/2000 SUPPL-19 Labeling

Label is not available on this site.

09/23/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/01/2000 SUPPL-17 Labeling

Label is not available on this site.

06/01/2000 SUPPL-16 Labeling

Label is not available on this site.

06/01/2000 SUPPL-15 Labeling

Label is not available on this site.

03/13/2009 SUPPL-14 Labeling

Label is not available on this site.

01/27/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/06/1997 SUPPL-12 Labeling

Label is not available on this site.

03/31/1998 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20152sltr.pdf
05/05/1997 SUPPL-10 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020152_s009s010_SERZONETOC.cfm
05/05/1997 SUPPL-9 Labeling Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020152_s009s010_SERZONETOC.cfm
12/02/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

01/13/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/2000 SUPPL-6 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020152_S006_SERZONE_AP.pdf
02/06/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/28/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/25/1996 SUPPL-3 Labeling

Label is not available on this site.

03/20/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/28/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/12/2005 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20152s035lbl.pdf

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