Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087771
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETAPRED | PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM | 0.25%;10% | 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 |
|---|---|---|---|---|---|---|---|
| 08/06/1993 | 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 |
|---|---|---|---|---|---|
| 01/18/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/1996 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1995 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |