Drugs@FDA: FDA-Approved Drugs
Company: MYLAN INSTITUTIONAL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEFOXIN IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
MEFOXIN IN PLASTIC CONTAINER | CEFOXITIN SODIUM | EQ 40MG BASE/ML | 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 |
---|---|---|---|---|---|---|---|
01/25/1993 | 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 |
---|---|---|---|---|---|
03/07/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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02/12/2009 | SUPPL-15 | Labeling |
Label is not available on this site. |
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01/31/2008 | SUPPL-14 | Labeling |
Label is not available on this site. |
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11/05/2004 | SUPPL-13 | Labeling |
Label is not available on this site. |
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02/06/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
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12/06/2004 | SUPPL-11 | Labeling |
Label is not available on this site. |
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06/04/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/04/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/06/2001 | SUPPL-8 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
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12/17/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/22/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
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05/31/1995 | SUPPL-5 | Labeling |
Label is not available on this site. |
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07/29/1996 | SUPPL-4 | Labeling |
Label is not available on this site. |
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04/04/1998 | SUPPL-3 | Labeling |
Label is not available on this site. |
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02/26/1996 | SUPPL-2 | Labeling |
Label is not available on this site. |
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07/11/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |