Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065245
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 02/15/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/04/2011 | SUPPL-5 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/21/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/16/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |