Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050624
Company: HOFFMANN LA ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER CEFTRIAXONE SODIUM EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER CEFTRIAXONE SODIUM EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER CEFTRIAXONE SODIUM EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
02/11/1987 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/14/2004 SUPPL-27 Labeling 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/2004/50585s057,50624s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50585s057,50624s027ltr.pdf
09/02/2004 SUPPL-26 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
11/21/2001 SUPPL-21 Labeling

Label is not available on this site.

10/18/1999 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

07/21/1997 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/20/1993 SUPPL-18 Labeling

Label is not available on this site.

08/18/1994 SUPPL-17 Labeling

Label is not available on this site.

02/22/1993 SUPPL-16 Labeling

Label is not available on this site.

04/26/1994 SUPPL-15 Labeling

Label is not available on this site.

12/04/1992 SUPPL-14 Labeling

Label is not available on this site.

03/01/1993 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/07/1993 SUPPL-12 Labeling

Label is not available on this site.

10/07/1993 SUPPL-11 Labeling

Label is not available on this site.

03/11/1991 SUPPL-10 Labeling

Label is not available on this site.

03/11/1991 SUPPL-9 Labeling

Label is not available on this site.

03/11/1991 SUPPL-8 Labeling

Label is not available on this site.

11/14/1988 SUPPL-7 Labeling

Label is not available on this site.

03/11/1991 SUPPL-6 Labeling

Label is not available on this site.

04/15/1991 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/18/1987 SUPPL-4 Labeling

Label is not available on this site.

06/18/1987 SUPPL-3 Labeling

Label is not available on this site.

06/22/1987 SUPPL-2 Labeling

Label is not available on this site.

05/22/1987 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/14/2004 SUPPL-27 Labeling 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/2004/50585s057,50624s027lbl.pdf
09/02/2004 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50585s056,50624s026lbl.pdf

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