Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
10/31/1993 | 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 |
---|---|---|---|---|---|
09/18/2017 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
10/03/2016 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2015 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
04/29/2015 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
02/28/2011 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
01/12/2010 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
03/26/2009 | SUPPL-28 | Labeling |
Label is not available on this site. |
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01/06/2005 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
04/11/2002 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
12/02/1999 | SUPPL-18 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
12/02/1999 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/10/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/07/2000 | SUPPL-15 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
02/12/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/12/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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01/08/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/28/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/18/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/13/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/28/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |