Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065001
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 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFUROXIME SODIUM | 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 |
|---|---|---|---|---|---|---|---|
| 05/30/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/65001ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/10/2011 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/20/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/12/2002 | 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. |