Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063127
Company: HIKMA
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 11/27/1991 | 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 |
|---|---|---|---|---|---|
| 01/17/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/1994 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/17/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |