Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLAFORAN | CEFOTAXIME SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CLAFORAN | CEFOTAXIME 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 |
---|---|---|---|---|---|---|---|
01/13/1987 | 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 |
---|---|---|---|---|---|
04/28/2010 | SUPPL-42 | Labeling |
Label is not available on this site. |
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11/02/2015 | SUPPL-41 | Labeling |
Label is not available on this site. |
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10/31/2008 | SUPPL-40 | Labeling |
Label is not available on this site. |
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11/01/2005 | SUPPL-35 | Labeling |
Label is not available on this site. |
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11/01/2005 | SUPPL-34 | Labeling |
Label is not available on this site. |
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06/18/2002 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
10/01/2001 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/13/2001 | SUPPL-29 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
03/19/2001 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
02/07/2001 | SUPPL-27 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
05/08/2000 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/09/1998 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/17/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/17/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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08/10/1998 | SUPPL-20 | Labeling |
Label is not available on this site. |
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12/20/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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12/20/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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07/31/1996 | SUPPL-15 | Labeling |
Label is not available on this site. |
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07/14/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/14/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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07/31/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/31/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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07/31/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
11/09/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/09/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/17/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/17/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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08/30/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |