Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064169
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFAZOLIN SODIUM | CEFAZOLIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 08/14/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/64169ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/29/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 04/26/2005 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/08/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/14/2003 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/07/2001 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |