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Drugs@FDA: FDA-Approved Drugs

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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ROCEPHIN CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INTRAMUSCULAR, INTRAVENOUS Discontinued None Yes No
ROCEPHIN CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No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
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
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