Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065111
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KANAMYCIN SULFATE | KANAMYCIN SULFATE | EQ 500MG BASE/2ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| KANAMYCIN SULFATE | KANAMYCIN SULFATE | EQ 1GM BASE/3ML | 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 |
|---|---|---|---|---|---|---|---|
| 12/17/2002 | 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 |
|---|---|---|---|---|---|
| 07/15/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2004 | SUPPL-2 | Labeling |
Label is not available on this site. |