Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062557
Company: LILLY
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEFZOL | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KEFZOL | CEFAZOLIN SODIUM | EQ 1GM 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 |
|---|---|---|---|---|---|---|---|
| 09/10/1985 | 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 |
|---|---|---|---|---|---|
| 09/30/2002 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-13 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 10/30/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/16/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/22/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |