Drugs@FDA: FDA-Approved Drugs
Company: FACTA FARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 20GM 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 |
|---|---|---|---|---|---|---|---|
| 12/27/1991 | 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 |
|---|---|---|---|---|---|
| 05/29/2016 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2012 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/06/2012 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/26/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/22/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/27/2006 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/27/2004 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 01/31/2001 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/30/2000 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/25/2001 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/30/1999 | SUPPL-9 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 06/10/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/13/1996 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/22/1994 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/29/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/22/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/19/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/12/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/16/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |