Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050585
Company: HOFFMANN LA ROCHE
Company: HOFFMANN LA ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | Yes | No |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | Yes | No |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | Yes | No |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | Yes | No |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| ROCEPHIN KIT | CEFTRIAXONE SODIUM; LIDOCAINE | EQ 1GM BASE/VIAL,N/A;N/A,1% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ROCEPHIN KIT | CEFTRIAXONE SODIUM; LIDOCAINE | EQ 500MG BASE/VIAL,N/A;N/A,1% | INJECTABLE;INJECTION | Discontinued | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 12/21/1984 | 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 |
|---|---|---|---|---|---|
| 07/12/2018 | SUPPL-68 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050585Orig1s068ltr.pdf | |
| 06/30/2015 | SUPPL-67 | 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/2015/50585s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s067ltr.pdf |
| 03/20/2015 | SUPPL-66 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050585Orig1s066ltr.pdf | |
| 04/12/2013 | SUPPL-65 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050585s065lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050585Orig1s065ltr.pdf | |
| 02/25/2010 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050585s064ltr.pdf | |
| 06/07/2009 | SUPPL-63 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/0550585s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050585s063ltr.pdf | |
| 11/12/2010 | SUPPL-62 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050585s062ltr.pdf | |
| 03/11/2009 | SUPPL-61 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050585s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050585s061ltr.pdf | |
| 08/18/2008 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050585s050,050585s060ltr.pdf | |
| 05/11/2007 | SUPPL-59 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s059ltr.pdf | |
| 07/17/2007 | SUPPL-58 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050585s058ltr.pdf | |
| 09/14/2004 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s057,50624s027ltr.pdf | |
| 09/02/2004 | SUPPL-56 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s056,50624s026ltr.pdf | |
| 03/29/2004 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585slr054_rocephin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585slr054ltr.pdf | |
| 08/18/2008 | SUPPL-50 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf | |
| 10/18/1999 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/28/1998 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/2000 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 12/23/1997 | SUPPL-46 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 09/14/1995 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 05/08/1996 | SUPPL-44 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 08/18/1994 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 02/04/1994 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1993 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/26/1994 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 03/14/1996 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1992 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/17/1992 | SUPPL-35 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-34 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 10/07/1993 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 09/12/1991 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/04/1992 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-27 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/11/1991 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 03/11/1991 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/11/1992 | SUPPL-23 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/29/1989 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1991 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/25/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1991 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 05/10/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/12/2018 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050585s068lbl.pdf | |
| 06/30/2015 | SUPPL-67 | 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/2015/50585s067lbl.pdf |
| 03/20/2015 | SUPPL-66 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050585s066lbl.pdf | |
| 04/12/2013 | SUPPL-65 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050585s065lbl.pdf | |
| 11/12/2010 | SUPPL-62 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s062lbl.pdf | |
| 02/25/2010 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050585s064lbl.pdf | |
| 06/07/2009 | SUPPL-63 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/0550585s063lbl.pdf | |
| 03/11/2009 | SUPPL-61 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050585s061lbl.pdf | |
| 08/18/2008 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf | |
| 08/18/2008 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050585s050s060lbl.pdf | |
| 07/17/2007 | SUPPL-58 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s058lbl.pdf | |
| 05/11/2007 | SUPPL-59 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050585s059lbl.pdf | |
| 09/14/2004 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s057,50624s027lbl.pdf | |
| 09/02/2004 | SUPPL-56 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf | |
| 03/29/2004 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585slr054_rocephin_lbl.pdf |