Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019387
Company: ALCON
Company: ALCON
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROFENAL | SUPROFEN | 1% | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/1988 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/18/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/01/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1993 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/21/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |