Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062654
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 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ROCEPHIN | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 04/30/1987 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/30/2004 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 07/26/2004 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 04/28/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 08/13/2002 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/22/2001 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 12/20/1999 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/18/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/04/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1994 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 02/23/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/15/1993 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/23/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/02/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 08/31/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/28/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1992 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/01/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |