Drugs@FDA: FDA-Approved Drugs
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| SERZONE | NEFAZODONE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| SERZONE | NEFAZODONE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| SERZONE | NEFAZODONE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| SERZONE | NEFAZODONE HYDROCHLORIDE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| SERZONE | NEFAZODONE HYDROCHLORIDE | 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| SERZONE | NEFAZODONE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |