Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063100
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 40MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1992 | 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 |
|---|---|---|---|---|---|
| 02/10/2023 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/18/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/18/2023 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/11/2023 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/09/2010 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2000 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/13/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/02/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/16/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/04/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/10/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |