Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 061773
Company: ACS DOBFAR
Company: ACS DOBFAR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEFZOL | CEFAZOLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| 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 |
| KEFZOL | CEFAZOLIN SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KEFZOL | 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 |
|---|---|---|---|---|---|---|---|
| 11/02/1973 | 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 |
|---|---|---|---|---|---|
| 05/29/2008 | SUPPL-66 | Labeling |
Label is not available on this site. |
||
| 09/18/2002 | SUPPL-63 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
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| 03/03/1999 | SUPPL-59 | Labeling |
Label is not available on this site. |
||
| 03/03/1999 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/1993 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 04/02/1993 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/07/1992 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 06/29/1992 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 10/29/1991 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/10/1991 | SUPPL-50 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1991 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/21/1991 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 11/21/1991 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 07/25/1991 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 07/10/1991 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |