Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064021
Company: APOTHECON
Company: APOTHECON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TOBRAMYCIN SULFATE | TOBRAMYCIN SULFATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1994 | 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 |
|---|---|---|---|---|---|
| 08/06/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/26/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/10/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |