Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062339
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| STATROL | NEOMYCIN SULFATE; POLYMYXIN B SULFATE | EQ 3.5MG BASE/ML;16,250 UNITS/ML | SOLUTION/DROPS;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 |
|---|---|---|---|---|---|---|---|
| 11/30/1984 | 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 |
|---|---|---|---|---|---|
| 08/04/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/14/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |