Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062592
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEFUROX | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAVENOUS | Discontinued | None | No | No |
| KEFUROX | CEFUROXIME SODIUM | EQ 1.5GM 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 |
|---|---|---|---|---|---|---|---|
| 01/10/1986 | 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 |
|---|---|---|---|---|---|
| 11/12/2002 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 09/30/2002 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/12/2002 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 09/04/2002 | SUPPL-23 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/24/2002 | SUPPL-22 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 01/22/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/22/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/22/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 01/13/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1997 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/30/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/12/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |