Drugs@FDA: FDA-Approved Drugs
Company: VALIDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLAFORAN | CEFOTAXIME SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CLAFORAN | CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CLAFORAN | CEFOTAXIME SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| CLAFORAN | CEFOTAXIME SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/11/1981 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/23/2015 | SUPPL-71 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050547Orig1s071,050596Orig1s042ltr.pdf |
| 02/21/2014 | SUPPL-70 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050547Orig1s070,050596Orig1s040ltr.pdf | |
| 09/09/2011 | SUPPL-68 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050547s068,050596s037ltr.pdf | |
| 05/27/2009 | SUPPL-67 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050547s067,050596s036ltr.pdf |
| 02/21/2008 | SUPPL-66 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050547s066ltr.pdf | |
| 09/02/2004 | SUPPL-61 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547s061ltr.pdf |
| 06/23/2004 | SUPPL-60 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50547slr060,50596slr030ltr.pdf |
| 02/22/2002 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2001 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/2001 | SUPPL-55 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/10/2001 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/18/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1998 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1998 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/28/1997 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/16/1998 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/18/2002 | SUPPL-47 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50547s47ltr.pdf |
| 04/24/1997 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/23/1996 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-42 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 08/25/1995 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/30/1996 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 06/29/1982 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 07/26/1982 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 02/23/1982 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 02/05/1982 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/19/1981 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 10/05/1981 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 07/22/1981 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1993 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/02/1994 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/14/1994 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/12/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/19/1993 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/1994 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/17/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/19/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/07/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/13/1981 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/24/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1985 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/14/1984 | SUPPL-7 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 02/29/1984 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/23/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1983 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/14/1983 | 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 |
|---|---|---|---|---|---|
| 03/23/2015 | SUPPL-71 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf |
| 02/21/2014 | SUPPL-70 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf | |
| 09/09/2011 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf | |
| 02/21/2008 | SUPPL-66 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf |