Drugs@FDA: FDA-Approved Drugs
Company: MYLAN INSTITUTIONAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEFOXIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| MEFOXIN | CEFOXITIN 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 |
|---|---|---|---|---|---|---|---|
| 01/08/1987 | 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 |
|---|---|---|---|---|---|
| 01/31/2008 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 12/02/2004 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 02/06/2004 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 02/06/2004 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 09/30/2002 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/04/2002 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 06/04/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/06/2001 | SUPPL-18 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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| 12/17/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/11/1997 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/22/2002 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 05/08/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1996 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 02/18/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/16/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/20/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/26/1996 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/11/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 03/10/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |