Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 009218
Company: BRISTOL MYERS SQUIBB
Company: BRISTOL MYERS SQUIBB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COUMADIN | WARFARIN SODIUM | 10MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 75MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| COUMADIN | WARFARIN SODIUM | 2MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 7.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 2.5MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 50MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| COUMADIN | WARFARIN SODIUM | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 4MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 5MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| COUMADIN | WARFARIN SODIUM | 3MG | TABLET;ORAL | Discontinued | None | Yes | No |
| COUMADIN | WARFARIN SODIUM | 6MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/08/1954 | 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 |
|---|---|---|---|---|---|
| 08/14/2017 | SUPPL-118 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/009218Orig1s118ltr.pdf | |
| 05/22/2017 | SUPPL-117 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf | |
| 09/08/2016 | SUPPL-116 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/009218Orig1s116ltr.pdf | |
| 10/28/2015 | SUPPL-115 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/009218Orig1s115ltr.pdf | |
| 12/02/2014 | SUPPL-114 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2013 | SUPPL-113 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/2010 | SUPPL-108 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/009218s108ltr.pdf | |
| 10/04/2011 | SUPPL-107 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/009218s107ltr.pdf | |
| 08/16/2007 | SUPPL-105 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/009218s105ltr.pdf | |
| 10/04/2006 | SUPPL-102 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/009218s102LTR.pdf | |
| 09/02/2005 | SUPPL-101 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/009218s101ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/009218_s101_coumadin.pdf | |
| 05/03/2002 | SUPPL-99 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s099ltr.pdf |
| 05/03/2002 | SUPPL-98 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/09218s098ltr.pdf |
| 02/17/2000 | SUPPL-97 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/09218S097_Coumadin.pdf |
| 07/09/1999 | SUPPL-96 | Labeling |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-95 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1999 | SUPPL-94 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1998 | SUPPL-93 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1998 | SUPPL-91 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf |
| 06/01/1998 | SUPPL-90 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf |
| 04/16/1998 | SUPPL-89 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1997 | SUPPL-88 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/23/1998 | SUPPL-87 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/01/1998 | SUPPL-86 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/009218a.pdf |
| 09/05/1996 | SUPPL-85 | Labeling |
Label is not available on this site. |
||
| 11/08/1996 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/18/1996 | SUPPL-83 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/07/1995 | SUPPL-80 | Labeling |
Label is not available on this site. |
||
| 03/08/1995 | SUPPL-79 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-77 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/28/1995 | SUPPL-76 | Efficacy-New Indication |
Label is not available on this site. |
||
| 08/06/1993 | SUPPL-75 | Labeling |
Label is not available on this site. |
||
| 03/31/1994 | SUPPL-74 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-73 | Labeling |
Label is not available on this site. |
||
| 02/01/1993 | SUPPL-72 | Labeling |
Label is not available on this site. |
||
| 08/20/1992 | SUPPL-71 | Labeling |
Label is not available on this site. |
||
| 08/24/1993 | SUPPL-70 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 12/15/1993 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/1991 | SUPPL-68 | Labeling |
Label is not available on this site. |
||
| 04/11/1991 | SUPPL-67 | Labeling |
Label is not available on this site. |
||
| 05/10/1991 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1990 | SUPPL-65 | Labeling |
Label is not available on this site. |
||
| 03/01/1990 | SUPPL-64 | Labeling |
Label is not available on this site. |
||
| 03/01/1990 | SUPPL-63 | Labeling |
Label is not available on this site. |
||
| 03/01/1990 | SUPPL-62 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-61 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/06/1987 | SUPPL-60 | Labeling |
Label is not available on this site. |
||
| 07/08/1986 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-56 | Labeling |
Label is not available on this site. |
||
| 02/25/1985 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 01/17/1985 | SUPPL-52 | Labeling |
Label is not available on this site. |
||
| 07/06/1987 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 12/29/1980 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/01/1980 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1980 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/06/1979 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/14/1978 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1977 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/11/1977 | SUPPL-33 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/27/1976 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 08/21/1975 | SUPPL-31 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/14/2017 | SUPPL-118 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf | |
| 08/14/2017 | SUPPL-118 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s118lbl.pdf | |
| 05/22/2017 | SUPPL-117 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf | |
| 05/22/2017 | SUPPL-117 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/009218s017lbl.pdf | |
| 09/08/2016 | SUPPL-116 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/009218s116lbl.pdf | |
| 10/28/2015 | SUPPL-115 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf | |
| 10/28/2015 | SUPPL-115 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/009218s115lbl.pdf | |
| 10/04/2011 | SUPPL-107 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/009218s107lbl.pdf | |
| 01/22/2010 | SUPPL-108 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/009218s108lbl.pdf | |
| 08/16/2007 | SUPPL-105 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009218s105lblv2.pdf | |
| 10/04/2006 | SUPPL-102 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/009218s102lbl.pdf | |
| 09/02/2005 | SUPPL-101 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/009218s101lbl.pdf |