Drugs@FDA: FDA-Approved Drugs
Company: NORVIUM BIOSCIENCE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEFOXIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
MEFOXIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
MEFOXIN | CEFOXITIN SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
10/18/1978 | 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 |
---|---|---|---|---|---|
03/09/2017 | SUPPL-53 | 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/2017/050517s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050517Orig1s053ltr.pdf |
05/10/2013 | SUPPL-51 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050517Orig1s051ltr.pdf | |
02/04/2011 | SUPPL-50 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050517s050ltr.pdf |
09/17/2007 | SUPPL-47 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050517s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050517s047ltr.pdf | |
06/02/2004 | SUPPL-46 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr046ltr.pdf | |
06/28/2004 | SUPPL-45 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf |
06/06/2002 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/07/2002 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/28/2004 | SUPPL-42 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50517slr042,045ltr.pdf |
10/19/2001 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/12/1999 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
04/24/1997 | SUPPL-39 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517S039_Mefoxin.pdf |
02/14/2000 | SUPPL-38 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-517s038_Mefoxin.cfm |
10/11/1996 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
11/30/1994 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/20/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
10/27/1994 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
05/20/1996 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
02/27/1997 | SUPPL-31 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/50-517s031_50-581s020_Mefoxin.cfm |
02/28/1995 | SUPPL-29 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
07/30/1996 | SUPPL-28 | Efficacy-New Indication |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/09/2017 | SUPPL-53 | 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/2017/050517s053lbl.pdf |
05/10/2013 | SUPPL-51 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050517s051lbl.pdf | |
09/17/2007 | SUPPL-47 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050517s047lbl.pdf | |
06/02/2004 | SUPPL-46 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50517slr046_mefoxin_lbl.pdf |