Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064093
Company: AKORN
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GENTAMICIN SULFATE | GENTAMICIN SULFATE | EQ 0.3% BASE | OINTMENT;OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1995 | 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 |
|---|---|---|---|---|---|
| 03/10/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/28/1995 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |