Drugs@FDA: FDA-Approved Drugs
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CONTAINER | CEFTRIAXONE SODIUM | EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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CONTAINER | CEFTRIAXONE SODIUM | EQ 20MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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CONTAINER | CEFTRIAXONE SODIUM | EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
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 |