Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065012
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOXITIN | CEFOXITIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFOXITIN | CEFOXITIN SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 07/03/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/65012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/065012_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/26/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/13/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 12/22/2000 | SUPPL-1 | Labeling |
Label is not available on this site. |