Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064201
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFOTAXIME | CEFOTAXIME SODIUM | EQ 10GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFOTAXIME | CEFOTAXIME 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 |
|---|---|---|---|---|---|---|---|
| 03/24/2000 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/64201ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/064201.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/30/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/21/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 03/17/2004 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 06/16/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 08/13/2002 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 03/28/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/04/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/2001 | SUPPL-1 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |