Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065002
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 7.5GM 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 |
|---|---|---|---|---|---|---|---|
| 09/28/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/65002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/65002_Cefuroxime.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/29/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/31/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 02/20/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/30/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/10/2002 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/28/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |