Drugs@FDA: FDA-Approved Drugs
Company: GLAXOSMITHKLINE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TIMENTIN | CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM | EQ 100MG BASE/VIAL;EQ 3GM 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 |
---|---|---|---|---|---|---|---|
12/19/1986 | 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 |
---|---|---|---|---|---|
06/27/2013 | SUPPL-54 | Labeling |
Label is not available on this site. |
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06/27/2013 | SUPPL-53 | Labeling |
Label is not available on this site. |
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03/04/2011 | SUPPL-52 | Labeling |
Label is not available on this site. |
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02/17/2009 | SUPPL-51 | Labeling |
Label is not available on this site. |
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06/28/2008 | SUPPL-50 | Labeling |
Label is not available on this site. |
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06/10/2008 | SUPPL-49 | Labeling |
Label is not available on this site. |
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07/06/2005 | SUPPL-47 | Labeling |
Label is not available on this site. |
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10/07/2003 | SUPPL-46 | Labeling |
Label is not available on this site. |
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10/07/2004 | SUPPL-45 | Labeling |
Label is not available on this site. |
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02/04/2004 | SUPPL-42 | Labeling |
Label is not available on this site. |
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12/09/2002 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/13/2002 | SUPPL-33 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
02/20/2002 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/01/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/31/2001 | SUPPL-29 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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08/31/2001 | SUPPL-28 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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01/24/2000 | SUPPL-22 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
10/25/1999 | SUPPL-21 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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03/11/1999 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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02/19/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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12/29/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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10/02/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/02/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/03/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/13/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
02/23/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/21/1994 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1993 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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09/16/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
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04/17/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/30/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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02/26/1990 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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12/05/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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04/20/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |