Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050585
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 INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL 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/2015/050585s067lbl.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/2015/050585s067lbl.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

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